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510(k) K251166

Mfinity Femoral System by Medacta International S.A. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2025
Date Received
April 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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