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510(k) K241059

Pantheon Proximal Femur Reconstruction (PFR) System by Adler Ortho S.P.A — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
April 18, 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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