SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS

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) Hybrid External Fixator Modifications.

Pre-market Notification Details

Device IDK073135
510k NumberK073135
Device Name:SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactJill Sherman
CorrespondentJill Sherman
SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester,  PA  19380
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-07
Decision Date2008-01-29
Summary:summary

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