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510(k) K260182

Avenir® Müller Stem; Avenir Complete™ Hip System by Zimmer, Inc. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2026
Date Received
January 21, 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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  • K251906 — Z1 Hip System (July 18, 2025)
  • K251292 — RECLAIM Monobloc Revision Femoral Stem (May 23, 2025)
  • K243927 — MobileLink Acetabular Cup System - inhouse coatings (May 16, 2025)
  • K250444 — NEXUS® Hip Stem (May 15, 2025)