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510(k) K243977

EMPHASYS Acetabular System by Depuy Ireland UC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2025
Date Received
December 23, 2024
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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