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510(k) K221938

KLS Martin Pure Pectus System by KLS Martin L.P. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2023
Date Received
July 1, 2022
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.

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  • 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)

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)