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510(k) K210961

U2 Total Knee System, XPE Tibial Insert, PS PLUS by United Orthopedic Corporation — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2021
Date Received
March 31, 2021
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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  • K221675 — United U2 femoral head, 22mm delta ceramic head (November 4, 2022)

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