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510(k) K232556

DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System by Depuy Ireland UC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2023
Date Received
August 23, 2023
Clearance Type
Special
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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