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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K142814
Device Name Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
Applicant
Biomet Manufacturing, LLC
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact TRACY BICKEL JOHNSON
Correspondent
Biomet Manufacturing, LLC
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact TRACY BICKEL JOHNSON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
KRO   LPH  
Date Received09/29/2014
Decision Date 06/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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