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510(k) K242315

Resolve Modular Revision Hip Stem by United Orthopedic Corporation — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2025
Date Received
August 5, 2024
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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