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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 K133940
Device Name OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
Applicant
Biomet UK, Ltd.
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact JASON HECKAMAN
Correspondent
Biomet UK, Ltd.
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact JASON HECKAMAN
Regulation Number888.3530
Classification Product Code
HRY  
Date Received12/23/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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