SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR

Plate, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) [synthes] Mini External Fixator.

Pre-market Notification Details

Device IDK971987
510k NumberK971987
Device Name:SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-05-29
Decision Date1997-06-24

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