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510(k) K251618

MOTO Partial Knee System Extension by Medacta International S.A. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2025
Date Received
May 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

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