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510(k) K221705

U2 Total Knee System-PF+ by United Orthopedic Corporation — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2023
Date Received
June 13, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
Review Panel
OR
Submission Type

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