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510(k) K222700

Tibial baseplate, Tibial insert by United Orthopedic Corporation — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 2022
Date Received
September 7, 2022
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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