Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 2016-08-03 · 007 device to sale by or on the...

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

MS303-1980 7

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Centimeter 1 2 3 4 5 6 7

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^7*7^77 ''' Bureau o '



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



-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) .êcuires 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 .?

.A44 ^^^Z^ t^wy^y ^y-ci^'^ - p ^ ^ r<^/<^ ^, ol-l Vi^

iRavigw:

7 "fnal .^3vi3w:

Ootional .âviaw;

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s.;iecui:-ve êctretar: '

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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. »"

SxS ten},_

°- ^ '°"'- 0.R B07. -are ^/^êdlca, " - '

^ .«fnrmatio»_„^::iAentiax .one o.;- - r - - con.--""' ^ ^ ,,..ea

r c ^ ^ - ..on .o .n.s . n . . . - — ^Tv attention

Your early ^ .-? Sincerely. ^^^^

Harry "^-^^^

HMK/r^^



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condyles' . hyses• femoral eP ^^^^^ ^^^^^^

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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)



- 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^

%



6359-1-050 SAMPLE Vitai«"'^Âiioy

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 VitaiiiumÂiioy

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 VitalliumÂlloy

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'taiiiumÂiioy


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^^


LOT NO ASNIS GUIDED SCREW 80MM LENGTH


no7 DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL



LOT NO


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^îîP'r^^l^^

CAT. NO. 6359-1-090 SAMPLE v^taitoÂiioy


XX GJS CAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS


" ^ ° 6359-1-095 SAMPLE VitalliumÂlloy

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 VitalliumÂlloy] IASNIS GUIDED SCREW lOOMM LENGTH LOT NO

• 6359-1-105 SAMPLE VitalliumÂlloy

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



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



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

•vitalKumÂUoyj

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


($1" Howmedica Inc Orthopaedics Division

" ''° 6359-1-125 SAMPLE Vitallium'Alloy


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 VitalliumÂlloy

LOT NO ASNIS GUIDED SCREW 12.SMM WASHER


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


iASNIS GUIDED SCREW 19MM WASHER

LOT NO

XX GJB

ICAUTION: FEDERAL LAW IN USA AND CANADA RESTRICTS THIS


($'Howmedica Inc o il; - Orthopaedics Division -"- 3^9 V.leiBrtS Bt.d Bulhottord N J 0,070



0549-1-050 SAMPLE stainless steel

LOT ND lASNIS GUIDED SCREW 150MM LENGTH



C\) Howmedica


LOT ND ASNIS GUIDED SCREW 60MM LENGTH


Ire, DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN OR HOSPITAL

l \ Howmedica Orthopci(>tii( s Division



LOT NO


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


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


XX GJB

Orttio();K'di( s Divisicjn ^\i Howmedica




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




^\i~ Howmedica iiK Orthop.R'ciics Division

[ C A T . NO. 0549-1-085 SAMPLE stainless steel


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


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


LOT ND ASNIS GUIDED SCREW 105 LENGTH



. \ Howmedica Or tfiof), iodic

&A3

£' c a ;

e::2i



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


ASNIS GUIDED SCREW 11SMM LENGTH

LOT NO



i\} Howmedica.Inc 0'}!y'yy7... :, Division




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



)<U'di( s Divisiofi [\i"Howmedica.Inc onyy.



IKST«Ml|Wg

iililiIiJj.ijjLLyJiiikIiiMiLMiikk.kl^^

Si



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



JHOWSE ggg} AN iNDEPENDon-BRITISH COMPANY D. HOWSE & COMPANY LIMITED, BEETHOVEN STREET, LONDON WIO 4LR. TELEPHONE: 01-960 5866.



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Questions? Contact FDA/CDRH/OCE/DID at CDRH … · 2016-08-03 · 007 device to sale by or on the...

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