Home / 510(k) Clearances / K072764

510(k) K072764

KLS MARTIN XTERNAL FIXATOR by KLS Martin L.P. — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2007
Date Received
September 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Mandibular Fixator And/Or Distractor
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

Other clearances by KLS Martin L.P.

  • K254162 — KLS Martin Ixos System (February 20, 2026)
  • 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)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • K183113 — DePuy Synthes Maxillofacial Portfolio - MR Conditional (March 13, 2019)
  • K181504 — Stryker Pediatric Mandibular Distractor 2 (September 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K133398 — STRYKER PEDIATRIC MANDIBLE DISTRACTOR (March 20, 2014)
  • K121502 — SYNTHES CURVILINEAR DISTRACTION SYSTEM (August 23, 2012)
  • K080458 — MIS CREST WIDENER (December 17, 2008)
  • K080542 — DISTRAX (December 15, 2008)