OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Oxford Fixed Lateral Bearing Partial Knee Replacement (oxford Tibial Trays A-f) Ixford Partial Knee Replacement System.

Pre-market Notification Details

Device IDK122277
510k NumberK122277
Device Name:OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactElizabeth Wray
CorrespondentElizabeth Wray
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeHRY  
CFR Regulation Number888.3530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-30
Decision Date2012-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304609884 K122277 000
00880304543447 K122277 000
00880304543430 K122277 000
00880304543423 K122277 000
00887868485541 K122277 000
00887868485534 K122277 000
00887868485527 K122277 000
00887868485510 K122277 000
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00880304543461 K122277 000
00880304543478 K122277 000
00880304609877 K122277 000
00880304609860 K122277 000
00880304543546 K122277 000
00880304543539 K122277 000
00880304543522 K122277 000
00880304543515 K122277 000
00880304543508 K122277 000
00880304543485 K122277 000
00887868485497 K122277 000

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