SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT

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 Sterile Mandible External Fixation Kit.

Pre-market Notification Details

Device IDK062299
510k NumberK062299
Device Name:SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-08
Decision Date2006-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98003305500S0 K062299 000

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