SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET

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 (usa) (synthes) Single Vector Distractor With Detachable Feet.

Pre-market Notification Details

Device IDK981075
510k NumberK981075
Device Name:SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
ClassificationExternal Mandibular Fixator And/or Distractor
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
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 Received1998-03-24
Decision Date1998-06-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10887587055893 K981075 000
10887587055886 K981075 000

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