Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Momm. VKsmm
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Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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^7*7^77 ''' Bureau o '
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
DEPARTMENT OF HEALTH AND HUfVIAN SERVICES PUBLIC HEALTH SERVICE
FOOD AND DRUG ADMINISTRATION SILVER SPRING. MARYLAND 209 IO ,
Section : 51 OK Received : 8/,l 9/80
Harr-y M. Kaufman Howmedica, Inc. 235 East 42nd Street New York, NY 10017
The information you have submitted as required by the above-referenced Section of the Federal Food, Drug, and Cosmetic Act has been received and each device has been assigned a unique document control number as indicated below'''. Please reference these document control numbers in any "future correspondence regarding these submissions.
We will notify you when processing has been completed or if any additional information is required. Questions concerning these submissions should be directed to:
Food and Drug Administration Bureau of Medical Devices Document Control Center (KFK-20) 8757 Georgia Avenue Silver Spring, MD 20910 (301) 427-7059
S in ce rely yo urs,
Anne M. Mastracci Acting Chief Document Control Center Bureau of Medical Devices
Device* Document Control No.
Asnis Guided Screw System UCLA Shoulder
K801969 K801970
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
-MEMORAND lilvi
TO Robert S. ,<annedy, PH.O.
DE?.^1=3^£2^T OF HSALTH, iDCCATION, .A4VD WSL5'.\iL£ ? ia t :c fflLu^nj savTcs
OATS;
rTlC.V< l l lLCil
I t fs (•ny recamnendation that tfte suoject STO(Jc) .Mot'lT'i'cit'ion:
y (A) Is suisstantiaHy atjyivalent ca marfcatad devicas
(3) .^ecuires arsnarket approval. NOT suoscantlal ly ecuv/ala.'i' ta ^narfcatad devicas
,(C) Se<?u1res OTrs data
(0) Is an fncaaiplata suinriss-fon (see Subm'ssion siieet)
Add i t iona I lev iswer 's Ccratents
Class Code with Panel .?
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f / T - ' L ^ /F ' ^
ja ta
tf^ .'ata
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Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Z 3 5 EAST
How* - ^ ^ ' " ^ ^ i i ^ * . H E ^ ^ ^ ^ ' ^
.OBK ^ ° ° ^ " ^ t K U - ^ ;
HAPR-' "^ omECTOR
. K A U F M A N
BEOUl-ft-.TOB-' ^fFAlBS
MiiBffl BB«f, August 15
1980
^ (HYK-20)
liiver sprxng. »"
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^ .«fnrmatio»_„^::iAentiax .one o.;- - r - - con.--""' ^ ^ ,,..ea
r c ^ ^ - ..on .o .n.s . n . . . - — ^Tv attention
Your early ^ .-? Sincerely. ^^^^
Harry "^-^^^
HMK/r^^
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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rtnretn^^tiTrovt^-^ " " ' components
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
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Material
The Asnis Guided Screw System will be manufactured in both Vitallium® and Stainless Steel.
Manufacturing Processes
Quality Assurance Procedures
General - finished products are 100% visually inspected and samples from each manufacturing lot are dimensionally inspected. Certain functional checks are made on a 100% basis.
Equivalent Products (Appendix C)
Mecron Cannulated Cancellous Screws (Mecron Medical Products) Howse Cannulated Screw (D. Howse and Co., Ltd.)
(b) (4)
(b) (4)
(b) (4)
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
- 3 -
i valent
' 7 7 i ^ ^ ^ ^ -^ - 7 Tcan-a- n -i n a e s r g n a n , .^^ * e Asnrs U „ a l he^ « ^ " YTTT^tY^ -^ - 7 Tcan-a-%r " " " : : s c r e « , U . e r s r - - n a X - -l V a % S ^ r a . a . e . e - ^ ^ ^ ^^ ^^^ , , „ , . . c e ^ . ^ „ . . .
^^n screw, - y as au -^he Wecron ^ -ce . i ^ =crevi. ^„v tha t i^
%
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
6359-1-050 SAMPLE Vitai«"'^^Aiioy
LOT NO IASNIS GUIDED SCREW 50MM LENGTH
XX GJS CAUTION FEDERAL UAW IN USA AND CANADA RESTRICTS THIS
ivc i DEVICE TO SALE DY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
6359-1-055 SAMPLE Vitaiiium^Aiioy
lASNIS GUIDED SCREW LOT NO 155MM LENGTH
XX GJ8 CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
IPQ Orthopaedics Division
••° 6359-1-060 SAMPLE Vilallium'Alloy
LOT NO IASNXS GUIDED SCREW 160MM LENGTH
XX GJS CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
6359-1-065 SAMPLE Vitallium^Alloy
ASNIS GUIDED SCREW 65MM LENGTH
LOT NO
XX GJB CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
noi DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
r ^ " H o w m e d i c a inr orthopaedics Division I (Vl H o W I T i e d i c a Inc Orthopaedics Division
'- 6359-1-070 SAMPLE V'taiiium^Aiioy
ASNIS GUIDED SCREW 70MM LENGTH
LOT NO
XX GJS CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
007 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
6359-1-075 SAMPLE V""-«'A"°v ASNIS GUIDED SCREW 75MM LENGTH
LOT NO
XX GJS CAUTION. FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
y ^ , • 1,
N'-a C ^ t i ^
:=h r - r i y ^ f-:*r^J
- T 1
y ^ r.iit, fr--«
^m ?;,,«
.-1
S ^ ' H o w m e d i c a inc orthopaedics Division I ($) H o w m e d i c a . i n c qi;!h2P?edics D^^
6359-1-080 SAMPLE Vitallium^Alloy
LOT NO ASNIS GUIDED SCREW 80MM LENGTH
XX GJS CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
no7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
6359-1-085 SAMPLE Vitallium^Alloy
ASNIS GUIDED SCREW 85MM LENGTH
LOT NO
XX GJB CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
no, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
( t ] " H c y w m e d i c a inc orthopaedics Division | S H o w m e d l c a . i n c . o^.l^^Pf^^i^iP'r^^l^^
CAT. NO. 6359-1-090 SAMPLE v^taito^Aiioy
LOT NO ASNIS GUIDED SCREW 90MM LENGTH
XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
" ^ ° 6359-1-095 SAMPLE Vitallium^Alloy
ASNIS GUIDED SCREW 9SMM LENGTH
LOT NO
C ^ " H o w m e d i c a Inc orthopaedics Division • [ $ HOWmed lCa . I nc
XX G j a CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
Orthopaedics Division
" 6359-1-100 SAMPLE Vitallium^Alloy] IASNIS GUIDED SCREW lOOMM LENGTH LOT NO
• 6359-1-105 SAMPLE Vitallium^Alloy
LOT NO
X X GJS i 1^1 O E v Y c g y O s l ° i r o . " o : r ".t-..-„^1 CANADA RESTRICTS THIS h p j y j M M | » ^ ^ ^ ^ ^ ^ ^ | l ^ ^ ^ ^ | ^ U f c H OF A PHYSICIAN OR HOSPITAL
$) Howmedica I nc. Orthopaedics Division
ASNIS GUIDED SCREW 105MM LENGTH
XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
G, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
(\) H o w m e d i c a inc orthopaedics Division
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
6359-i-UO .AMPLE ^ ^ ^ ASNIS GUIDED SCREW UOMM LENGTH
XX GJSI
W CAUTION; FEDERAL LAW IN U-SA AND CANADA RESTRICTS THIS I no, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
6359-1-120 SAMPLE ASNIS GUIDED SCREW I12OMM LENGTH
•vitalKum^AUoyj
LOT NO
XX GJ8
CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
11 ILLLyiJ4ILI (SiHowmedica Orthooaedics Division
,inc yyy:?yxy> — - ^ "-y
6359-1-130 SAMPLE v«um-AHoy|
ASNIS GUIDED SCREW LOT Nol I13OMM LENGTH I XX GJsl I CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS I re7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
($)Howmedica .r- Orthopaedics Division
6359-2-160 SAMPLE Vitallium' Alloy
CAT, NO.
6359-1-115 SAMPLE ASNIS GUIDED SCREW H5MM LENGTH
Vitallium*Alloy I
LOT NO
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
007 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
($1" Howmedica Inc Orthopaedics Division
" ''° 6359-1-125 SAMPLE Vitallium'Alloy
ASNIS GUIDED SCREW 125MM LENGTH
LOT NO
XX GJS CAUTION. FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
($" H o w m e d i c a inc orthopaedics Division
iASNIS GUIDED SCREW 16MM WASHER
LOT NO
XX GJB
I CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS 007 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
^"Howmedica Orthopaedics Division V . ' .' y.t :«,.rt 0„m,rto.8 N J 07070
C A T . N O . 6359-2-125 SAMPLE Vitallium^Alloy
LOT NO ASNIS GUIDED SCREW 12.SMM WASHER
XX GJS CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
^ : i
i:r:.ra
m m as
cS)"Howmedica. inc . o l opa dic Division
6359-2-190 SAMPLE Vitallium^Alloy
iASNIS GUIDED SCREW 19MM WASHER
LOT NO
XX GJB
ICAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
($'Howmedica Inc o il; - Orthopaedics Division -"- 3^9 V.leiBrtS Bt.d Bulhottord N J 0,070
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
0549-1-050 SAMPLE stainless steel
LOT ND lASNIS GUIDED SCREW 150MM LENGTH
XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
07 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
C\) Howmedica
0549-1-060 SAMPLE stainless steel
LOT ND ASNIS GUIDED SCREW 60MM LENGTH
XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
Ire, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
l \ Howmedica Orthopci(>tii( s Division
0549-1-070 SAMPLE stainless steel
ASNIS GUIDED SCREW 70MM LENGTH
LOT NO
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
b07 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
[ V i H o w m e d i c a Ire Orthopaedics Division
CAT. NO 0549-1-080 SAMPLE stainless steel
ASNIS GUIDED SCREW SOMM LENGTH
LOT NO
XX GJB CAUTION FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
K7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
($1 Howmedica Orthop.H'dies Division
CAT. NO. 0549-1-090 SAMPLE stainless steel
LOT NO ASNIS GUIDED SCREW 90MM LENGTH
XX GJB 1 CAUTION- FEDERAL LAW IN USA AND CANADA RESTRICTS THIS I re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL_
S H o w m e d i c a Inc Orthop. iodics Division
0549-1-055 SAMPLE stainless Steell
LOT NO IASNIS GUIDED SCREW 55MM LENGTH
XX GJB
Orttio();K'di( s Divisicjn ^\i Howmedica
0549-1-065 SAMPLE stainless steel
LOT NO ASNIS GUIDED SCREW 65MM LENGTH
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
t j o , DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
C i Howmedica Ortt iop, icdic ,s Division
CAT. NO, 0549-1-075 SAMPLE stainless steel
LOT NO ASNIS GUIDED SCREW 75MM LENGTH
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
^\i~ Howmedica iiK Orthop.R'ciics Division
[ C A T . NO. 0549-1-085 SAMPLE stainless steel
ASNIS GUIDED SCREW 85MM LENGTH
LOT NO
XX GJB CAUTION FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
I re , DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
ci l H o w m e d i c a . I n c OrY !:>yyd Y: , Division
f c A T , NO. 0549-1-095 SAMPLE stainless steel
LOT NO ASNIS GUIDED SCREW 95MM LENGTH
XX GJB , CAUTION- FEDERAL LAW IN USA AND CANADA RESTRICTS THIS I re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
C\i Howmedica Orthop.u'dK s Division
0549-1-105 SAMPLE stainless steel
LOT ND ASNIS GUIDED SCREW 105 LENGTH
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
. \ Howmedica Or tfiof), iodic
&A3
£' c a ;
e::2i
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
0549-1-120 SAMPLE IASNIS GUIDED SCREW 120MM LENGTH
Stainless Steell
LOT NO
XX GJB I CAUTION- FEDERAL LAW IN USA AND CANADA RESTRICTS THIS Ire, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIANORHOSPITAL_
V) Howmed ica Inc Orthop.iodK s Division
0549-1-115 SAMPLE stainless steel
ASNIS GUIDED SCREW 11SMM LENGTH
LOT NO
XX GJB CAUTION; FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
i\} Howmedica.Inc 0'}!y'yy7... :, Division
0549-1-125 SAMPLE stainless steel
LOT NO IASNIS GUIDED SCREW 125MM LENGTH
XX GJB CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
c^DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
< \ H o w m e d i c a . I n c . Orthop,ic(k .s Division-
0549-1-130 SAMPLE ASNIS GUIDED SCREW 130MM LENGTH
stainless Steel
LOT NO
XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS
re, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL
)<U'di( s Divisiofi [\i"Howmedica.Inc onyy.
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
IKST«Ml|Wg
iililiIiJj.ijjLLyJiiikIiiMiLMiikk.kl^^
Si
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
Mecronf Cannulated Cancellous Screvs s MADE FROM 316 L HIGH GRADE STAINLESS STEEL
mimMimmmri]
inserting of guide wire. Countersink is applied over guide wire to open outer cortex.
Inserting of screw over guide wire using the cannulated screwdriver , .:,yy---•:.
Canuiated screws to be inserted over a guide wire.
indications: yyyyyy'::-y^-:'' ., Olecranon Fractures, Shoulder Fractures, Hip Arthrodesis, Epiphysiolvsis, Femoral Neck Fractures, Femoral Condyle Fractures, Lower and upper Tibia Fractures etc.
Final compression of fracture. Removal of guide wire. y -.'---.yy
Mecron medical Products P.O. Box 480129 1000 Berlin 48 West-Germany
in Canada. RO. Box 2418 Downsview, Ontario M3N2V9
MECRON Advanced engineering orthopaedic implants
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118
JHOWSE ggg} AN iNDEPENDon-BRITISH COMPANY D. HOWSE & COMPANY LIMITED, BEETHOVEN STREET, LONDON WIO 4LR. TELEPHONE: 01-960 5866.
Records Processed under FOIA Request # 2015-7966; Released by CDRH on 12-4-2015
Questions? Contact FDA/CDRH/OCE/DID at [email protected] or 301-796-8118