Mandible External Fixator - MR Conditional

External Mandibular Fixator And/or Distractor

Synthes USA Products, LLC

The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Mandible External Fixator - Mr Conditional.

Pre-market Notification Details

Device IDK143285
510k NumberK143285
Device Name:Mandible External Fixator - MR Conditional
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant Synthes USA Products, LLC 1302 Wrights Lane West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
Synthes USA Products, LLC 1302 Wrights Lane West Chester,  PA  19380
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-11-17
Decision Date2015-05-28

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