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510(k) K254162

KLS Martin Ixos System by KLS Martin L.P.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2026
Date Received
December 22, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by KLS Martin L.P.

  • K250620 — KLS Martin Ixos System (August 15, 2025)
  • K221938 — KLS Martin Pure Pectus System (March 28, 2023)
  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • K173320 — KLS Martin L1 MMF System (February 23, 2018)
  • K163579 — KLS Martin Individual Patient Solutions (November 21, 2017)
  • K163315 — Internal Distraction - Sterile (May 5, 2017)
  • K170124 — Level One Hand Plating System (March 9, 2017)
  • K161259 — KLS Martin Cannulated Headless Screws (December 19, 2016)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • K151983 — KLS Martin LSS Plating System (April 6, 2016)