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510(k) K243466

Conformity Stem Extension Line, #0 by United Orthopedic Corporation — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2025
Date Received
November 8, 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

Other clearances by United Orthopedic Corporation

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  • K242315 — Resolve Modular Revision Hip Stem (May 1, 2025)
  • K243024 — Cellbrick Knee Spacer (December 20, 2024)
  • K242249 — Conformity Stem Extension Line (August 30, 2024)
  • K221705 — U2 Total Knee System-PF+ (February 28, 2023)
  • K221149 — U-Motion II Acetabular System-Extension line (January 5, 2023)
  • K221675 — United U2 femoral head, 22mm delta ceramic head (November 4, 2022)
  • K222700 — Tibial baseplate, Tibial insert (October 6, 2022)

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  • K251906 — Z1 Hip System (July 18, 2025)
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  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)