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510(k) K053299

REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT by Biomet Manufacturing, Inc. — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2006
Date Received
November 25, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
Review Panel
OR
Submission Type

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