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510(k) K183113

DePuy Synthes Maxillofacial Portfolio - MR Conditional by Synthes (USA) Products, LLC — Product Code MQN

K183113 is an FDA 510(k) premarket notification submitted by Synthes (USA) Products, LLC for the device "DePuy Synthes Maxillofacial Portfolio - MR Conditional". The FDA issued a decision of Substantially Equivalent on March 13, 2019. 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
March 13, 2019
Date Received
November 9, 2018
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

  • K254087 — MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System (June 11, 2026)
  • K212943 — SyntheCel Dura Repair (January 28, 2022)
  • K211313 — MAXFRAME Multi-Axial Correction System (aka MAXFRAME) (May 25, 2021)
  • K210408 — DePuy Synthes Variable Angle Locking Patella Plating System (April 8, 2021)
  • K210205 — DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Platin (March 26, 2021)
  • K201346 — DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Scr (September 23, 2020)
  • K192702 — DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional (September 18, 2020)
  • K201944 — DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (September 10, 2020)
  • K201578 — DePuy Synthes Variable Angle Locking Patella Plating System (September 9, 2020)
  • K201336 — DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails (September 3, 2020)

Other clearances for product code MQN

  • K220050 — KLS Martin IPS Distraction (August 11, 2022)
  • 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)
  • K080153 — SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM (May 14, 2008)

FDA data resources