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510(k) K243809

Biolox® Delta Revision heads by Limacorporate — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2025
Date Received
December 11, 2024
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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