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510(k) K212761

Biocore9 Acetabular Cup System by Biocore9, LLC — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2022
Date Received
August 31, 2021
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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