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510(k) K100973

EVOLUTION UNICONDYLAR KNEE SYSTEM by Wrightmedicaltechnologyinc — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2010
Date Received
April 8, 2010
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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