SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK950384
510k NumberK950384
Device Name:SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli,  PA  19301
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-01
Decision Date1995-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679392180 K950384 000
H6793937460 K950384 000
H6793937450 K950384 000

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