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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer
510(k) Number K122277
Models 154200 TO 154239 AS PER TAB B, SECT 4, 159530;154600/03; 161467/71 PER TAB B, SECT 4
Device Name OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM
Original Applicant
BIOMET MANUFACTURING CORP.
56 east bell drive
p.o. box 587
warsaw,  IN  46581 0587
Original Contact elizabeth wray
Regulation Number888.3530
Classification Product Code
HRY  
Date Received07/30/2012
Decision Date 10/22/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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