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510(k) K241018

KLS Martin Orthopedic Implants - MR Conditional by KLS-Martin L.P. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2024
Date Received
April 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by KLS-Martin L.P.

  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K250988 — KLS Martin Pure Pectus System (December 11, 2025)
  • K250865 — KLS Martin IPS Forearm System (November 14, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K233721 — KLS Martin Drill-Free MMF Screw (September 17, 2024)
  • K241314 — KLS Martin Oral-Max Implants MR Conditional (bundled) (August 16, 2024)
  • K230211 — CranioXpand (November 21, 2023)
  • K222624 — KLS Martin LINOS Wrist System (May 25, 2023)
  • K222397 — KLS Martin Level One Rib Fixation System (March 29, 2023)
  • K210731 — KLS Martin Individual Patient Solutions (July 18, 2022)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)