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510(k) K080542

DISTRAX by John W. King — Product Code MQN

K080542 is an FDA 510(k) premarket notification submitted by John W. King for the device "DISTRAX". The FDA issued a decision of Substantially Equivalent on December 15, 2008. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2008
Date Received
February 27, 2008
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 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)
  • K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (May 14, 2008)

FDA data resources