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510(k) K251052

Trivicta® Hip Stem by Ortho Development Corp. — Product Code MEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2025
Date Received
April 3, 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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