SYNTHES MANDIBLE EXTERNAL FIXATOR

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 External Fixator.

Pre-market Notification Details

Device IDK050378
510k NumberK050378
Device Name:SYNTHES MANDIBLE EXTERNAL FIXATOR
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeMQN  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-15
Decision Date2005-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679394990 K050378 000
H980033051050 K050378 000
H980033055000 K050378 000
H980043051280 K050378 000
H980043051300 K050378 000
H980043051340 K050378 000
H980043051380 K050378 000
H980043051400 K050378 000
H980043051420 K050378 000
H679292790 K050378 000
H679392240 K050378 000
H980SD4490100 K050378 000

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