Craniomaxillofacial Distraction System (CMFD)

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 Craniomaxillofacial Distraction System (cmfd).

Pre-market Notification Details

Device IDK162594
510k NumberK162594
Device Name:Craniomaxillofacial Distraction System (CMFD)
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES USA PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester,  PA  19380
ContactNicholas Fountoulakis
CorrespondentNicholas Fountoulakis
SYNTHES USA PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester,  PA  19380
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-16
Decision Date2017-05-08
Summary:summary

NIH GUDID Devices

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