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510(k) K260037

implantcast Packaging System Update by Implantcast GmbH — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2026
Date Received
January 6, 2026
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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Other clearances for product code LZO

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  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)