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510(k) K143285

Mandible External Fixator - MR Conditional by Synthes USA Products, LLC — Product Code MQN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2015
Date Received
November 17, 2014
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

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  • 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)
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  • K141897 — SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM (September 25, 2014)
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Other clearances for product code MQN

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  • K181504 — Stryker Pediatric Mandibular Distractor 2 (September 11, 2018)
  • K162594 — Craniomaxillofacial Distraction System (CMFD) (May 8, 2017)
  • K161470 — Internal Distraction - Sterile (December 1, 2016)
  • 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)