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510(k) K234025

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads by Howmedica Osteonics Corp., Dba Stryker Orthopaedics — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2024
Date Received
December 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

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