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510(k) K210678

implaFit® hip stems by Implantcast GmbH — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2022
Date Received
March 5, 2021
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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  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)