SYNTHES MANDIBLE DISTRACTOR

External Mandibular Fixator And/or Distractor

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Mandible Distractor.

Pre-market Notification Details

Device IDK962272
510k NumberK962272
Device Name:SYNTHES MANDIBLE DISTRACTOR
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-13
Decision Date1996-08-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9802879540 K962272 000
H9802879530 K962272 000

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