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510(k) K252401

implaFit® short stems by Implantcast GmbH — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2026
Date Received
July 31, 2025
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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