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510(k) K162594

Craniomaxillofacial Distraction System (CMFD) by Synthes USA Products, LLC — Product Code MQN

K162594 is an FDA 510(k) premarket notification submitted by Synthes USA Products, LLC for the device "Craniomaxillofacial Distraction System (CMFD)". The FDA issued a decision of Substantially Equivalent on May 8, 2017. The device falls under product code MQN (External Mandibular Fixator And/Or Distractor), a Class II device regulated under 21 CFR 872.4760. Synthes USA Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2017
Date Received
September 16, 2016
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 Synthes USA Products, LLC

  • K180541 — DePuy Synthes 2.0 mm Quick Insertion Screws (November 21, 2018)
  • K170818 — Craniomaxillofacial Distraction System (CMFD) (December 7, 2017)
  • K170654 — USS System (March 29, 2017)
  • K161616 — DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated S (February 16, 2017)
  • K162358 — T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System (November 1, 2016)
  • K151276 — DePuy Synthes T-PAL Ti Spacer (June 18, 2015)
  • K143285 — Mandible External Fixator - MR Conditional (May 28, 2015)
  • K142838 — Synapse Occipital-Cervical-Thoracic (OCT) System (January 20, 2015)
  • K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (September 25, 2014)
  • K133698 — SYNAPSE SYSTEM (January 16, 2014)

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)
  • 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)
  • K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (May 14, 2008)

FDA data resources