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510(k) K183113

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

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

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  • 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)
  • K191463 — DePuy Synthes Hammertoe Continuous Compression Implant (February 26, 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)