SYNTHES LCP DISTAL FEMUR PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Distal Femur Plates.

Pre-market Notification Details

Device IDK062564
510k NumberK062564
Device Name:SYNTHES LCP DISTAL FEMUR PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
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 Received2006-08-31
Decision Date2006-10-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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