SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4mm Lcp Volar Column Distal Radius Plates.

Pre-market Notification Details

Device IDK091644
510k NumberK091644
Device Name:SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactKarl J Nittinger
CorrespondentKarl J Nittinger
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-04
Decision Date2009-12-23
Summary:summary

NIH GUDID Devices

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