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510(k) K210695

CPM Medical Consultants Tibial Revision Knee System by Cpm Medical Consultants, LLC — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
March 8, 2021
Clearance Type
Traditional
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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