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510(k) K242232

Mpact 3D Metal Augments II by Medacta International S.A. — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2025
Date Received
July 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

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