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510(k) K210010

GMK Revision & Hinge Extension - TiNbN Coating by Medacta International S.A. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2021
Date Received
January 4, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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