4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM

Condylar Plate Fixation Implant

SYNTHES USA

The following data is part of a premarket notification filed by Synthes Usa with the FDA for 4.5mm Va-lcp Curved Condylar Plate System.

Pre-market Notification Details

Device IDK110354
510k NumberK110354
Device Name:4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM
ClassificationCondylar Plate Fixation Implant
Applicant SYNTHES USA 1301 GOSHEN PKWY West Chester,  PA  19380
ContactThomas N Shea
CorrespondentThomas N Shea
SYNTHES USA 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeJDP  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-07
Decision Date2011-03-04
Summary:summary

NIH GUDID Devices

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