13m~e TECHNICAL FILE - DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2
Revision: 2
REF: SOP 2.1 .2 TECHNICAL FILE PROCEDURE Date Issued: 04/21/11 Page: I of 16
Technical File - Declaration of Conformity Technical File: Trauma Fixation Instrumentation
Authoritl·d Europrau Community \\\•till• :\lanufal'IUrl'I": Rrprrsrulath rand l.orntion of
lks >011sihll• l'rrson: Biomet Trauma PO Box 587 56 East Bell Drive Warsaw, IN 46581-0587 USA ~800-348-9500
Biomet U.K. Limited Waterton Industrial Estate South Wales Bridgend CF 31 3XA United Kingdom ct..44-1656-655221 11144-1656-645454
We hereby declare under our sole responsibility that the following products meet the classification, requirements, relevant directive provisions, harmonized standards, normative documents, registrations and certifications referenced below and within the technical file referenced above.
Orthopedic Instrumentation
Trauma Fixation Instrumentation
Part number listing below
Class Ila Per Rule 6 of Annex IX of the Council Directive 93/42/EEC concerning medical devices i.e. Medical Device Directive - MOD.
Council Directive 93/42/EEC and subsequent amendments concerning medical devices, i.e, Medical Device Directive - MOD:
Annex I Essential Re uirements Annex II EC Declaration of Conformi
Certificate No.
FMS798Sl Notified Bod
BSI Product Services Kitemark Court
EC Certificate - Full Assurance CMDCAS Certificate
Notified Bod No.: 0086
Declaration of Conformity Prepared Date: 18May1013
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 2 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 1001 4.8/6.5mm Step Drill 47563
1002 5.3MM DRILL BIT 47563
1069 CANNULATED REAMER 6.5MM 45115
1077 BALL NOSE GUIDEWIRE 3.0 35685
1127 EXCHANGE TUBE 47831
1138 3.8MM DRILL 47563
1253 TWIST DRILL 5.3MM X 6IN 47563
1285 3.8MM. CANNULATED REAMER 45115
1526 CALIBRATED DRILL 4.4MM 47563
1731 2.9MM CALIB.TWIST DRILL 47563
1735 HUMERAL ENTRY REAMER 45115
1741 3.8MM CALIB.TWIST DRILL 47563
1742 3.6/4.9MM CALIB.STEP DRIL 47563
1746 4.5/5.0 SOLID COUNTERSINK 16462
2617 3.8MM 3-FLUTE TRO.DRILBIT 47563
2619 3.8 3-F CAL.TRO.DRILL SQC 47563
2631 4.5MM SOLID LOCK DRIVER 33968
2645 5.3MM CALIB.DRILL QC 47563
13547 EASYOUT 47633
13548 CANNULATED COUNTERSINK 16462
13585 4.0 CANN.CANCEL. TAP 47562
14016 NON-ADJUSTABLE STEP DRILL 47563
14043 3.8MM DRILL BIT 47563
14447 5.5MM CANNULATED DRILL 47563
14541 4.5MM SOLID SCREWDRIVER 33968
14545 3.8MM SOLID DRILL 7IN 47563
14569 CALIBRATED LAG SCREW TAP 17507
14584 6.5MM SOLID CANCEL.TAP 47562
14616 6.5 SCREWDRIVER 33968
14620 EASY OUT 4.5/6.5 SCRW.SYS 47633
14621 3.8MM TWIST DRILL 47563
14622 3.8MM CANNULATED DRILL 47563
14623 4.5MM CORTICAL TAP 47562
14624 5.0MM CANCELLOUS TAP 47562
14625 4.8MM TWIST DRILL 47563
14626 4.8MM CANNULATED DRILL 47563
14627 6.5MM CANCELLOUS TAP 47562
14628 6.5MM COUNTERSINK 16462
14629 5.0MM CANNULATED DRILL 47563
14634 8.0MM CANCELLOUS TAP 47562
14663 SOLID SCREWDRIVER 3.5MM 33968
25008 REAMER 28MM 45115
25013 REAMER/TAP 28MM 17507
104059 2MM STEINMAN PIN 9IN 35685
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 3 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 107528 GUIDEWIRE 3.2MM X 28 35685
107538 GUIDEWIRE 3.2MM X 38 35685
140129 GUIDE WIRE 3.2X230MM 35685
141401 CANN HOLE SAW PRIMARY 14147
141403 CANN HOLE SAW SECONDARY 14147
141796 2MM X 6IN ST PIN HALF BAY PT 35685
141799 2MM X 9IN ST PIN HALF BAY PT 35685
141806 3.2MM X 6IN ST PIN HALF BAY PT 35685
145851 ADJUST.REAMER-SHORT 45115
145852 ADJUSTABLE REAMER MEDIUM 45115
145853 ADJUSTABLE REAMER-LONG 45115
172428 GUIDEWIRE 2.2MM X 28 35685
1354070 CANN.SCREWDRIVER 70MM 33968
1354270 SOLID SCREWDRIVER 70MM 33968
1355070 2.9 SOLID DRILL 70MM 47563
1355570 2.9 CANN. DRILL 70MM 47563
1356070 3.5 SOLID TWIST DRILL 70M 47563
1356470 4.0 SOLID TWIST DRILL 70M 47563
1357070 3.5 SOLID CORT.TAP 70MM 47562
1358070 4.0 SOLID CANCEL.TAP 70MM 47562
1401214 3.2MM X 14IN SHRT THRD GD PIN 35685
13540120 CANN SCREWDRIVER SHAFT 120MM 33968
13542120 SOLID SCREWDRIVER SHAFT 120MM 33968
13550120 2.9 SOLID DRILL, 120mm 47563
13560120 3.5 SOLID TWIST DRILL120M 47563
13564120 4.0 SOLID TWIST DRILL 120MM 47563
13570120 3.5 SOLID CORT.TAP 120MM 47562
13580120 4.0 CANCEL.TAP 120MM 47562
113909070 0.9X70MM PIN STE 35685
113910070 1.0MM DIA X 70MM KWIRE-STE(x3) 35685
113910100 K-WIRE 1.0X100MM STE 35685
113910170 1.0MM DIAX70MM KWIRE SNGL-STE 35685
113918062 1.8X52MM KATSUYA DRILL STE 43390
113920001 2.0mm CANN 1-STEP DRILL-STE 43390
113920002 2.0 SHORT CANN 1STEP DRILL-STE 43390
113920003 2.0MM CANN 1STEP DRILL OB-STE 43390
113920004 2.0MM DIA KATSUYA DRILL-STE 43390
113920011 2.2MM CANNULATED DRILL STE 43390
113920012 2.5MM AO DRILL STE 43390
113920013 2.5MM DRILL W/O LOCK STE 43390
113920062 2.0X62MM KATSUYA DRILL STE 43390
113925062 2.5X62MM CANNULATED DRILL STE 43390
113930062 3.0X62MM CANNULATED DRILL STE 43390
180010000 S S BIT 3-1/2X1/16 47563
180012000 S S BIT 3-1/2X5/64 47563
180014000 S S BIT 3-1/2X3/32 47563
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 4 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 180016000 S S BIT 3-1/2X7/64 47563
180018000 S S BIT 3-1/2X1/8 47563
180020000 S S BIT 3-1/2X9/64 47563
180022000 S S BIT 3-1/2X5/32 47563
180023000 S S BIT 3-1/2X11/64 47563
180024000 S S BIT 3-1/2X3/16 47563
180110000 S S BIT 5X1/16 47563
180112000 S S BIT 5X5/64 47563
180114000 S S BIT 5X3/32 47563
180116000 S S BIT 5X7/64 47563
180118000 S S BIT 5X1/8 47563
180120000 S S BIT 5X9/64 47563
180122000 S S BIT 5X5/32 47563
180123000 S S BIT 5X11/64 47563
180124000 S S BIT 5X3/16 47563
182110000 DRILL BIT 1/4X7 47563
182111000 DRILL BIT 5/16X7 47563
182112000 DRILL BIT 3/8X7 47563
210426000 GUIDE PIN 3.2MM BALL NOSE 35685
210428000 GUIDE PIN 3.2MM DRILL PT 35685
211201102 ENTRY REAMER SOLID SHAFT 45115
211201103 ENTRY REAMER FLEXIBLE SHAFT 35297
211201303 LAG SCREW DRILL 32390
211201309 5MM HEX DRIVER SET SCREW 33968
211201310 LAG SCREW TAP 17507
211201321 LAG SCREW DRILL 80/90MM 32390
211201405 4.3MML DISTAL GRADUATED DRILL 43390
211201406 4.3MMS DISTAL GRADUATED DRILL 43390
211201409 3.5MMS HEX DRIVER DISTAL SCREW 33968
211201410 4.3MM DRILL MEASURING SLEEVE 58148
211201411 4.3MML DISTAL GRADUATED DRILL JACOBS 43390
211201412 4.3MMS DISTAL GRADUATED DRILL JACOBS 43390
211201504 3.5MML HEX DRIVER AR/DIST SCRW 33968
211201505 A/R SCREW DRILL 43390
211201506 A/R SCREW REMOVAL TOOL 33968
211201507 A/R SCREW DRILL JACOBS 43390
211201509 CROWN ENTRY REAMER 45115
211201600 5MM HEX DRIVER END CAP 33968
211201601 5MM HEX CANN DRIVER END CAP 33968
211201602 END CAP REMOVAL TOOL 33968
212000002 SCREW DRIVER STE 58776
212000003 DEPTH GAUGE STE 58796
212000008 1.6MM KWIRE TROCHAR TIP STE 35685
212000010 DVR PLATE TEMPLATE SET STERILE 58804
212000022 2.2MM DRILL BIT STE 43390
212000122 2.2MM DRILL GUIDE STE 57789
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 5 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 212000222 SOFT TISSUE GUIDE 2.2MM 57789
212957010 DRILL BIT 2.8MM STERILE 43390
212957012 DRILL BIT 3.2MM STERILE 43390
212957014 DRILL BIT 4.0MM STERILE 43390
212957016 DRILL BIT 4.8MM STERILE 43390
212958010 CLAVICLE PIN 2.5MM TAP 17507
212958012 CLAVICLE PIN 3.0MM TAP 17507
212958014 CLAVICLE PIN 3.8MM TAP 17507
212958016 CLAVICLE PIN 4.5MM TAP 17507
214108001 ANCHOR BOLT 47847
214111001 4.5MM PERCUTANEOUS SCRWDRIVER 33968
214113032 3.2MM CALIBRATED DRILL BIT 47563
214113132 3.2x280MM CALIBRATED DRILL STE 43390
214114038 3.8MM CALIBRATED DRILL BIT 47563
214114138 3.8x280MM CALIBRATED DRILL STE 43390
214115000 4.5MM SOLID DRILL 47563
214115100 4.5x216MM DRILL STE 43390
214116000 4.5MM NONLOCKING CORTICAL TAP 47562
214116200 4.5x255 NONLOCK CORT TAP STE 56708
214116245 4.5x272MM LOCK CORT TAP STE 56708
214116545 4.5MM LOCKING CORTICAL TAP 47562
214121000 5.0MM CANN HEX DRIVER SHORT HD 33968
214123000 5.5MM CANNULATED DRILL BIT 47563
214123100 5.5X165MM CANN DRILL HD STE 43390
214126025 2.5 MM HEX EXTRACT HUDSON 47633
214126035 3.5 MM HEX EXTRACTOR HUDSON 47633
214126135 3.5 MM HEX EXTRACT LONG HUDSON 47633
214129000 2.5MM CALIBRATED DRILL BIT 47563
214129100 2.5X261MM CALIBRATED DRILL STE 43390
214141000 4.5 SCREWDRIVER S-CP 33968
214142000 CANN COUNTERSINK S-CP 16462
214143000 3.8MM CANN DRILL BLT S-CP 47563
214143100 3.8X150MM CANN DRILL STE 43390
214144000 4.5MM CANN DRILL BLT S-CP 47563
214144100 4.5X150MM CANN DRILL STE 43390
214145000 4.5MM CANN CORT TAP S-CP 47562
214145100 4.5MM CANN CORT TAP STE 56708
214146000 5.0MM CANN CANC TAP S-CP 47562
214146100 5.0MM CANN CANC TAP STE 56708
214202012 BALL SPIKE PUSHER 47874
214203038 3.8 CALIBRATED DRILL BIT 47563
214204007 PEAK FX LAG SCREW DRIVER 33968
214204023 PEAK FX KEY SCREW DRIVER 33968
214214001 5.0MM HEX DRIVER SHANK 33968
214214002 5.0MM CANNULATED DRILL 47563
214214012 5.0MM CANNULATED DRILL LONG AO 47563
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 6 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 214214300 GUIDE WIRE 3.2X300 35685
214215070 T-15 TAPERED DRIVER 33968
214226035 PEAK FX 3.5MM HEX EXTRACTOR 47633
214227070 2.7MM CALIB DRILL BIT 47563
214227071 2.7MM CALIB DRILL BIT 100MM 47563
214227160 2.7X160MM CALIBRATED DRILL STE 43390
214235006 2.7 MM DRILLBIT 100 MM 47563
214235007 2.5MM DRILL BIT 100 MM 47563
214235200 DRILL MEASURING SLEEVE 100 MM 47831
214288006 2.0 DRILL MEAS SLEEVE SHORT 47831
214288007 INSERT MULTI DIRECT 2.0MM 33968
214288008 MARKED DRILL BIT SHORT 2.0MM 47563
214288009 4.5MM CANC THREADED PIN AO 35685
231200101 1.7 MM SQUARE DRIVER 33968
231200102 1.7 MM SQUARE DRIVERMQC END 33968
231200200 2.2 MM DRILL BIT 47563
231200201 2.9 MM DRILL BIT 47563
231201300 DRILL BIT 3.3MM 43390
231201301 DRILL BIT F.A.S.T.2.0MM 43390
231201302 DRILL BIT 2.5MM 43390
231201303 STAINLESS STEEL K-WIRE 062 35685
231201306 DRILL F.A.S.T. 4.0MM LONG STE 43390
231201307 DRILL F.A.S.T 4.0MM SHORT STE 43390
231201308 DRILL F.A.S.T. 4.0MM STEP STE 43390
231201309 DRILL 2.8MM (DISTAL SCR) STE 43390
231201310 STAINLESS STEEL K-WIRE 2.0 STE 35685
231204006 SNP DRILL BIT JUMBO 47563
231204012 F A S T PEG DRIVER JUMBO 33968
231211001 INSERT CAPTIVE HEX 2.5MM 33968
231211002 MDTP DRIVER MINI QK CONNECT 33968
231218014 2.5 MM COUNTERBORE 16462
231218016 SHORT F.A.S.T. GUIDE 57789
231218021 T-15 TAPERED DRIVER SHORT 33968
231220200 1.0MM DRILL BIT MINI-QUICK CON 47563
231220201 1.3MM DRILL BIT MINI-QUICK CON 47563
231220202 FAST 1.1MM DRILLBIT MINIQUICK 47563
231220203 1.5MM DRILL BIT MINI-QUICK CON 47563
231220204 FAST 2.0MM DRILLBIT MINIQUICK 47563
231220205 2.5MM DRILL BIT MINI-QUICK CON 47563
231220206 1.3MM/1.5MM COUNTERSINK 47634
231220207 2.0MM/2.5MM COUNTERSINK 47634
231220208 1.3MM DRIVER BIT 47563
231220209 1.5MM DRIVER BIT 47563
231221200 1.0X56MM DRILL MQC STE 43390
231221201 1.3X56MM DRILL MQC STE 43390
231221202 1.1X56MM DRILL FAST MQC STE 43390
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 7 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 231221203 1.5X56MM DRILL MQC STE 43390
231221204 2.0X81MM DRILL FAST MQC STE 43390
231221205 2.5X81MM DRILL MQC STE 43390
246114447 5.5X150MM CANNULATED DRILL 43390
246114627 6.5MM CANN CANCELLOUS TAP STE 56708
246114629 5.0X150MM CANNULATED DRILL 43390
246114634 8.0MM CANN CANCELLOUS TAP STE 56708
246140129 3.2X230 THRD GUIDE PIN STE 35685
281001011 JIG BOLT DRIVER 5.0MM 33968
281001015 4.5/5.5MM SCREWDRIVER SHAFT 33968
281001016 COUNTERSINK SHAFT 16462
281001019 SOLIDLOK HEX TIP 3.5MM 47633
281001036 GUIDE PIN 3.6MM X 14 35685
281001037 5.0MM HEX DRIVER LONG 33968
281001041 3.6X355MM BAYONET GD PIN STE 35685
281001080 BALL NOSE GUIDE WIRE 80CM 35685
281001100 BALL NOSE GUIDE WIRE 100CM 35685
281001119 SOLIDLOK 3.5MM HEX TIP STE 58776
281001140 3.2X355MM THRD GUIDE PIN STE 35685
281001175 3.2X444MM THR GUIDE PIN STE 35685
281002015 150MM REAMER EXTENSION 45115
281002060 6MM MONOBLOC REAMER HUDSON 45115
281002065 6.5 MM MONOBLOC REAMER HUDSON 45115
281002070 7MM MONOBLOC REAMER HUDSON 45115
281002075 7.5MM MONOBLOC REAMER HUDSON 45115
281002080 8MM MONOBLOC REAMER HUDSON 45115
281002081 8MM MNBLC ENDCUT REAM HUDSON 45115
281002085 8.5MM MONOBLOC REAMER HUDSON 45115
281002090 9MM MONOBLOC REAMER HUDSON 45115
281002091 9MM MNBLC ENDCUT REAM HUDSON 45115
281002095 9.5MM MONOBLOC REAMER HUDSON 45115
281002100 10MM MONOBLOC REAMER HUDSON 45115
281002105 10.5MM MONOBLOC REAMER HUDSON 45115
281002110 11MM MONOBLOC REAMER HUDSON 45115
281002115 11.5MM MONOBLOC REAMER HUDSON 45115
281002120 12MM MONOBLOC REAMER HUDSON 45115
281002400 400MM NITINOL MOD REAMER HUDSN 35297
281002401 VERSA RMR 400MM CAPTRD SHAFT 35297
281002470 470MM NITINOL MOD REAMER HUDSN 35297
281002476 VERSA RMR 470MM CAPTRD SHAFT 35297
281003065 6.5MM MONOBLOC REAMER AO END 45115
281003070 7MM MONOBLOC REAMER AO END 45115
281003075 7.5MM MONOBLOC REAMER AO END 45115
281003401 VERSA RMR 400MM AO CAPTRD SHAFT 35297
281003476 VERSA RMR 470MM AO CAPTRD SHAFT 35297
281004090 9.0MM MODULAR REAMER HEAD 45115
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 8 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 281004091 VERSA 9MM END CUT MOD RMR HEAD 35297
281004095 9.5MM MODULAR REAMER HEAD 45115
281004100 10.0MM MODULAR REAMER HEAD 45115
281004105 10.5MM MODULAR REAMER HEAD 45115
281004110 11.0MM MODULAR REAMER HEAD 45115
281004115 11.5MM MODULAR REAMER HEAD 45115
281004120 12.0MM MODULAR REAMER HEAD 45115
281004125 12.5MM MODULAR REAMER HEAD 45115
281004130 13.0MM MODULAR REAMER HEAD 45115
281004135 13.5MM MODULAR REAMER HEAD 45115
281004140 14.0MM MODULAR REAMER HEAD 45115
281004145 14.5MM MODULAR REAMER HEAD 45115
281004150 15.0MM MODULAR REAMER HEAD 45115
281004155 15.5MM MODULAR REAMER HEAD 45115
281004160 16.0MM MODULAR REAMER HEAD 45115
281004165 16.5MM MODULAR REAMER HEAD 45115
281004170 17.0MM MODULAR REAMER HEAD 45115
281004175 17.5MM MODULAR REAMER HEAD 45115
281004180 18.0MM MODULAR REAMER HEAD 45115
281004185 18.5MM MODULAR REAMER HEAD 45115
281004190 19.0MM MODULAR REAMER HEAD 45115
281004195 19.5MM MODULAR REAMER HEAD 45115
281004200 20.0MM MODULAR REAMER HEAD 45115
281004205 20.5MM MODULAR REAMER HEAD 45115
281004210 21.0MM MODULAR REAMER HEAD 45115
281004215 21.5MM MODULAR REAMER HEAD 45115
281004220 22.0MM MODULAR REAMER HEAD 45115
281012002 11.5MM ENTRY REAMER TIBIA 45115
281012028 11.5MM ENTRY REAMER TIBIA 45115
281012038 3.8X150MM DRILL STE 43390
281012041 VERSA TIBIA STD COMPRESS ROD 47875
281012042 VERSA TIBIA EXTND COMPRESS ROD 47875
281012044 4.4X285MM DRILL STE 43390
281012138 3.8MM DRILL BIT 6IN NS 47563
281012144 4.4MM DRILL BIT NS 47563
281012238 3.8MM CAL DRILL 6IN NS JACOBS 47563
281012244 4.4MM CAL DRILL NS JACOBS 47563
281013001 12MM ENTRY REAMER FEMUR 45115
281013002 13MM ENTRY REAMER FEMUR 45115
281013003 14MM ENTRY REAMER FEMUR 45115
281013024 6.5MM SCREWDRIVER SHAFT 33968
281013028 13MM ENTRY REAMER FEMUR AO 45115
281013029 14MM ENTRY REAMER FEMUR AO 45115
281013037 FLEXIBLE JIG BOLT DRIVER 8MM 33968
281013038 3.8X210MM DRILL STE 43390
281013046 VERSA FEM UNIV COMPRESS ROD 47875
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 9 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 281013053 5.3X362MM DRILL STE 43390
281013065 6.5/4.8MMX363MM STEP DRILL STE 43390
281013138 3.8MM DRILL BIT 8IN NS 47563
281013153 5.3MM DRILL BIT NS 47563
281013165 6.5/4.8MM STEP DRILL BIT NS 47563
281013238 3.8MM DRILL BIT 8IN NS JACOBS 47563
281013453 5.3MM DRILL BIT NS JACOBS 47563
281013465 6.5/4.8MM STEP DRILL NS JACOBS 47563
281013553 5.3MM DRILL BIT NS 32390
281017003 UNIV NAIL ENTRY REAMER 9.4MM 45115
281017004 UNIVERSAL RETRO ENTRY REAMER 45115
281017006 2.0MM BALL NOSE GUIDE WIRE 35685
281017015 3.8MM DRILL BIT 43390
281017017 HUMERAL SCREWDRIVER 33968
281017019 2.9MM DRILL BIT 43390
281017022 UNIVERSAL NAIL EXTRACTOR BOLT 12696
281017024 COUNTERSINK 16462
281017026 Humeral Nail Exchange Tube Ste 57789
281017029 2.9MM DRILL BIT SHORT S 43390
281017115 3.8MM DRILL BIT 47563
281017119 2.9MM DRILL BIT 47563
281017129 2.9MM DRILL BIT SHORT NS 47563
281017215 3.8 CAL HUM DRILL NS JACOBS 47563
281017219 2.9 CAL HUM DRILL NS JACOBS 47563
281017229 2.9 CAL HUM DRILL 6IN NS JACBS 47563
281018002 PROX NAIL ENTRY REAMER 11.5MM 45115
290326000 DRILL BIT 2.7MM 47563
290328000 DRILL BIT 3.5MM 47563
290329000 DRILL BIT 1.5MM 47563
290330000 DRILL BIT 2.0MM 47563
290332000 DRILL BIT 3.2MM 47563
290336000 DRILL BIT 4.5MM 47563
330908050 0.8MM DIA X 50MM KWIRE-STE(x3) 35685
330918001 1.8DIA CANN 1-STEP DRILL-STE 43390
330918002 1.8DIA SHRT CANN 1STP DRIL-STE 43390
362120001 PACK PF1 - D12 48012
362120002 PACK PF2 - D12 48012
362120003 PACK EPIPHYSEAL - D12 48012
362120004 PACK ASSEMBLE BAR - D12 48012
362120005 PACK WRIST 48012
362180001 PACK PF1 - D18 48012
362180002 PACK PF2 - D18 48012
362180003 PACK EPIPHYSEAL - D18 48012
362180004 PACK ASSEMBLE BAR - D18 48012
363120150 PACK 1 CARBON BAR 12x150 48012
363120200 PACK 1 CARBON BAR 12x200 48012
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 10 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 363120250 PACK 1 CARBON BAR 12X250 48012
363120300 PACK 1 CARBON BAR 12X300 48012
363120350 PACK 1 CARBON BAR 12X350 48012
363120400 PACK 1 CARBON BAR 12X400 48012
363180250 PACK 1 CARBON BAR 18X250 48012
363180300 PACK 1 CARBON BAR 18X300 48012
363180350 PACK 1 CARBON BAR 18X350 48012
363180400 PACK 1 CARBON BAR 18X400 48012
809222028 GUIDEWIRE 2.2MM X 28IN 35685
809230028 GUIDEWIRE 3.0MMX28IN BALL 35685
809230038 GUIDEWIRE 3.0MM BALL NOSE 35685
809232228 GUIDEWIRE 3.2MM X 28IN 35685
809232238 GUIDEWIRE 3.2MM X 38IN 35685
810710000 SS PIN SELF DRILL TAP NS 35685
810710002 5.0X233MM SELF-DRILL PIN STE 35685
814099380 TI MINI 1.1MM DRILL BIT 47563
816299001 PROVISIONAL FIXATION PIN 20MM 35685
816299006 PROVISIONAL FIXATION PIN 40MM 35685
816299009 3.8MM CALIBRATED DRILL BIT 47563
816299010 4.5MM LOCKING CORTICAL TAP 47562
816299013 3.8MM SOLID DRILL BIT 47563
816299109 3.8x235MM CALIBRATED DRILL STE 43390
816299110 4.5X150MM LOCK CORT TAP STE 56708
816299113 3.8X173MM SOLID DRILL STE 43390
816301000 2.2 MM SQUARE DRIVER 33968
816301005 MEASURING DRILL SLEEVE 47831
816301009 2.0MM MARKED DRILL BIT 47563
816301016 2.0MM MEASURE DRILL SLEEVE 47831
820040000 5.3MMX13IN TWIST DRILL 47563
820508000 DRILL CANN ENTRY 13.5MM 47563
820711000 ENTRY REAMER 8.5MM 45115
820745004 3.8MM CALIBRATED TWIST DRILL 47563
820745038 3.8mm TTC DRILL STE 43390
820755004 4.4MM CALIBRATED TWIST DRILL 47563
820755044 4.4mm TTC DRILL STE 43390
821056000 3.5MM SCREWDRIVER 33968
821059000 EASY OUT 47633
821060000 3.0MM TREPHINE 14147
821061000 3.5MM TREPHINE 14147
821062000 4.5MM TREPHINE 14147
821063000 6.5MM TREPHINE 14147
821064000 3.5MM EXTRACTION BOLT 47633
821065000 4.5MM EXTRACTION BOLT 47633
821066000 6.5MM EXTRACTION BOLT 47633
821067000 3.5MM SCREW EXTRACTOR 47633
821068000 4.5MM SCREW EXTRACTOR 47633
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 11 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 821508000 LAG SCREW TAP REGULAR 47562
821509000 LAG SCREW TAP SUPER 47562
824135077 3.5MM LOCKING CORTICAL TAP 47562
824135177 3.5X140MM LOCK CORT TAP STE 56708
824150070 3.5 MM SOLID CORT TAP 70MM 47562
824150170 3.5X140MM CORTICAL TAP STE 56708
824156070 SCRDVR CANN S-CP 3.5MM 33968
824157071 SOLID SCREWDRIVER SHANK S-CP 33968
824158000 COUNTERSINK CANN SCOUPLE 16462
824158100 COUNTERSINK SMALL FRAG 16462
824159000 EASY OUT S-COUPLE 47633
824160070 TAP CORT S-CP 3.5X70MM 47562
824160120 TAP CORT S-CP 3.5X120MM 47562
824161070 TAP CANC S-CP 4.0X70MM 47562
824161120 TAP CANC SS-CP 4.0X120MM 47562
824161170 4.0X140MM CANCELLOUS TAP STE 56708
824161220 4.0X190MM CANCELLOUS TAP STE 56708
824162000 TAP CAN CANC SCP 4.0X70MM 47562
824162100 4.0X140MM CANN CANC TAP STE 56708
824167000 3.5MM CANN CORT TAP S-COUPLE 47562
824167100 3.5X140MM CANN CORT TAP STE 56708
824219000 4.5/6.5 SCR DRVR SHANK 33968
824220000 4.5/6.5 SOLID COUNTERSIN 16462
824220100 4.5/6.5 SOLID COUNTERSINK 16462
824245170 4.5X150MM CORTICAL TAP STE 56708
824272000 3.8MM SOLID DRILL BIT 47563
824273000 4.5MM SOLID DRILL BIT 47563
824273100 4.5X150MM Drill STE 43390
824274000 4.5MM SOLID CORTICAL TAP 47562
824275000 6.5MM SOLID CANC TAP 47562
824275100 6.5x195MM CANCELLOUS TAP STE 56708
824299000 PROVISIONAL FIXATION PIN SHORT 35685
824299001 PROVISIONAL FIXATION PIN LONG 35685
824299102 SFS PROV FIXATION PIN STE 35685
824299103 SFS PROV FIXATION PIN LONG STE 35685
829029070 DRILL BIT 2.5MM 47563
829029170 2.5X140MM DRILL STE 43390
829030070 DRILL CANN S-CP 2.9X70MM 47563
829030170 2.9X140MM CANN DRILL STE 43390
829031070 DRILL TWIST SCP 2.9X70MM 47563
829031120 DRILL TWIST SCP 2.9X120MM 47563
829031170 2.9X140MM DRILL STE 43390
829032009 3.2MM CALIBRATED GUIDE PIN 35685
829032070 DRILL TWIST SCP 3.5X70MM 47563
829032120 DRILL TWIST SCP 3.5X120MM 47563
829032170 3.5X140MM DRILL STE 43390
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 12 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 829032315 3.2X145MM DRILL STE 43390
829032382 2.0X120MM DRILL STE 43390
829033070 DRILL TWIST SCP 4.0X70MM 47563
829033170 4.0X140MM DRILL STE 43390
829034070 DRILL CANN SCP 3.5X70MM 47563
829034170 3.5X70MM CANN DRILL STE 43390
829131120 2.9X190MM DRILL STE 43390
829132009 3.2X230MM CALIBRATED PIN STE 35685
829516150 1.6X150 BAYONET GUIDE PIN STE 35685
829516151 1.6x150MM THRD GUIDE PIN STE 35685
833004004 2.5X444MM THRD GUIDEWIRE STE 35685
837820230 2.0x230MM THRD GUIDE WIRE STE 35685
839999185 2.5X230MM THRD GUIDE WIRE STE 35685
839999251 3.5X110MM DRILL STE 43390
839999254 4.0X110MM CANCELLOUS TAP STE 56708
839999316 4.5X145MM DRILL STE 43390
839999319 4.5X125MM CORTICAL TAP STE 56708
839999386 2.7X145MM CORTICAL TAP STE 56708
839999580 2.5X110MM DRILL STE 43390
839999586 3.5X110MM CORTICAL TAP STE 56708
851417960 2.0X150 BAYONET GUIDE WIRE STE 35685
856301005 MEASURING DRILL SLEEVE STE 58148
903001001 CANNULATED ENTRY REAMER 17MM 45115
903003004 3.2MM THREADED GUIDE PIN 35685
903003206 ATN LNG LAG SCREW STEP DRILL 47563
903004004 2.5 MM GUIDE PIN 35685
903004105 ATN AR SCREW STEP DRILL 47563
903005004 3.8 MM DRILL 47563
937418400 DRILL TIPP OLIVE WIRE 1.8x400 35685
939999184 GUIDE WIRE 2.5 X 300MM 35685
939999185 GUIDE PIN 2.5MM X 230MM 35685
939999188 COMBINATION REAMER SHORT 45115
939999189 COMBINATION REAMER LONG 45115
939999201 SCS COMBINATION REAMER 45115
939999312 3.5MM DRILL BIT (145/120MM) 32390
939999315 DRILL BIT 3.2 MM DIA. 32390
939999316 DRILL BIT 4.5 MM DIA. 32390
939999380 DRILL BIT 1.1 MM DIA QC 32390
939999381 DRILL BIT 1.5 MM DIA QC 32390
939999382 DRILL BIT 2.0 MM DIA QC 32390
939999383 DRILL BIT 2.7 MM DIA QC 32390
939999465 MINI SCREW MODULE 12143
939999580 DRILL BIT 2.5MM (GOLD) 32390
939999581 DRILL BIT 2.5MM (LONG) 32390
939999582 DRILL BIT 2.5MM (JACOBS CHUCK) 32390
939999583 DRILL BIT 3.5MM (LONG) 32390
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 13 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code 939999584 DRILL BIT 3.5MM (JACOBS CHUCK) 32390
939999585 DRILL BIT 3.5MM LG.JAC.CHUCK 32390
939999713 DRILL BIT 2.7/1.35 CANN 32390
939999714 COUNTERSINK 4MM CANN SCREW 16462
939999716 2.5 SCREWDRIVER 4MM CANN SCRW 33968
939999717 MEASURING DEVICE 4MM CANN SCRW 32845
939999718 CLEANING BRUSH 1.35MM DIA 44802
939999719 STYLET, 1.25MM DIA 15275
939999725 CHS ONE STEP COUPLING SCREW 47847
939999750 CAN.4.5mm DRILL BIT 11332
A11523 DRILL BIT FOR 3MM PIN 47563
A3906 DRILL Ø3.5 – CANNULATED Ø1.7 MM 32390
A4162 DRILL Ø5.5 – CANNULATED Ø1.7 MM 32390
A4209 MECHE KATSUYA D2MM 32390
A4209ER KATSUYA DRILL D2MM QUICK C 32390
A5229 MECHE CANULEE COURTE 32390
A5232 MECHE CANULEE LONGUE 32390
A6311 PIN DIA 0.9MM – LENGTH 70MM 35685
A6312 KATSUYA DRILL DIAMETER 2MM 32390
A6313 THREADED PIN DIA 2MM – 70MM 46165
A6315 CANNULATED DRILL DIA 3.0MM 11332
DB20 DRILL BIT 2.0MM 47563
DB25 DRILL BIT 2.5MM 47563
DB28 DRILL BIT 2.8MM 47563
DB33 DRILL BIT 3.3MM 47563
DB40L DRILL BIT 4.0MM LONG 47563
DB40S DRILL BIT SHORT 4.0MM 47563
DBS40 DRILL BIT 4.0MM STEP 47563
FDB20 DRILL BIT FAST 2.0MM 47563
FDB40L DRILL BIT FAST 4.0MM LONG 47563
FDB40S DRILL BIT FAST 4.0MM SHORT 47563
FDS40 DRILL BIT FAST 4.0MM STEP 47563
FF10503 DRILL 5MM FISCHER 35647
FF10551 5MM TIP CAP 48011
GA1355070 BOHRER,DURCHM.2,9MM,LäNGE 70MM (2.9 SOLID DRILL 70MM) 47563
GA1355570 KANUL. BOHRER, DURCHM. 2,9X 70 (2.9 CANN. DRILL 70MM) 47563
GA1356070 BOHRER MIT AO-SCHNELLANSCHLUSS (3.5 SOLID TWIST DRILL 70MM) 47563
GA1356470 BOHRER MIT AO-SCHNELLANSCHLUSS (4.0 SOLID TWIST DRILL 70MM) 47563
GA14621 BOHRER, DURCHM. 3,8 MM (3.8MM TWIST DRILL) 47563
GG1355570 KANUL.BOHRER, DURCHM. 2,9MM, (2.9 CANN. DRILL 70MM) 47563
KW062 KWIRE 1.6MM TI 35685
KW062SS KWIRE 1.6MM SS 35685
KW20SS KWIRE 2.0MM SS 35685
M43850 BROCHE GUIDE 20/10 200 MM 46165
M43852 BROCHE GUIDE 25/10X200MM 46165
M43870 PT TARIERE D7 LG 185 45115
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 14 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
Catalog / Product No. Description GMDN Code M43872 GRANDE TARRIERE DIAM 14 200 MM 45115
M48500 BROCHE GUIDE 25/10X200MM 46165
M48550 REAMER 45115
M49200 BROCHE GUIDE 18/10 200 MM 46165
M49210 VISEUR GRADUE GLORION 35095
M49230 TARIERE D 5,5 MM GLORION 45115
M49250 TARIERE D 8,5 MM GLORION 45115
M68714 CORTICAL SCREW TAP Ø4.5 MM 17507
MDP015 MECHE DE PERCAGE 1.5 32390
MDP035 DRILL BIT 3.5MM DIA 32390
MDP045 DRILL BIT 4.5MM DIA 32390
MDP055 DRILL BIT 5.5MM DIA 32390
PA247 MEC PERCEE SCARF 2 INCL 32390
PA247ER SCARF DRILLBIT 2 INCL QUICK C 32390
PA248 SCARF DRILLBIT 2 INCL 32390
PA248ER SCARF DRILLBIT 2INCL QUICK C 32390
PA251 SCARF DRILLBIT 2 32390
PA374 DRILLBIT 2.5 MDF 2.2 32390
PA375 DRILLBIT 2.5 VERROU 32390
PA379 2.5 DRILL 32390
PA390 LAME SCIE WEIL/SYNTHES 44985
PA392 LAME DE WEIL TYPE SYNTHES 44985
PA395 LAME DE SCIE WEIL/ 44985
SNDB40 DRILL BIT SNP 4.0MM 47563
SNPG20 SHOULDER PIN GUIDE 2.0MM 57789
TC1 4MM TIP CAP 48011
TC2 3MM TIP CAP 48011
GMDN Code(s): 11332 – Cannulated Surgical Drill 12696 – Orthopeadic implant inserter/extractor 14147 – Bone Trephine 16462 – Surgical Countersink, reusable 17507 – Bone Tap, reusable 32390 – Non-Sterile fluted drill, reusable 33968 – Surgical screwdriver, reusable 35095 – Surgical drill guide, reusable 35297 – Medullary canal orthopaedic reamer, flexible 35647 – External Orthopaedic fixation system, reusable 35685 – Orthopaedic bone wire 43390 – Sterile fluted surgical drill 44802 – Orthopaedic instrument cleaning tool 44985 - Reciprocating surgical saw blade, reusable 45115 – Manual canal orthopaedic reamer, rigid 46165 – Bone Nail Guidewire 47562 – Bone tap, single use, non-sterile 47563 – Non-sterile fluted surgical drill, single-use
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 15 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
47633 – Surgical screwdriver, single-use, non-sterile 47634 – Surgical countersink, single-use 47831 – Surgical Instrument Sleeve Reusable 47847 – Orthopaedic implant/instrument adaptor, reusable 48011 – External Orthopeadic fixation system, single-use, non-sterile 48012 – External Orthopeadic fixation system, single-use, sterile 56708 – Bone tap, single-use, sterile 57789 – Surgical drill guide, single-use 58776 – Surgical screwdriver, single-use, sterile 58148 – Surgical instrument sleeve single-use 58796 – Surgical depth gage, single-use 58804 – Surgical implant template, single-use
TECHNICAL FILE – DECLARATION OF CONFORMITY Document Number: INST. 2.1.2.2Revision: 2 Date Issued: 04/21/11 Page: 16 of 16 REF: SOP 2.1.2 TECHNICAL FILE PROCEDURE
Declaration of Conformity Prepared Date: 28 May 2013
REV. DATE DESCRIPTION OF CHANGE 1 05/25/10 New 2 04/21/11 Added additional column and note for GMDN codes for clarity.