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510(k) K110547

OPTERTRAK LOGIC PSC TIBIAL INSERT by Exactech Sarasota — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2011
Date Received
February 25, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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