SYNTHES LCP ANKLE ARTHRODESIS 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 Ankle Arthrodesis Plates.

Pre-market Notification Details

Device IDK061940
510k NumberK061940
Device Name:SYNTHES LCP ANKLE ARTHRODESIS 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 Received2006-07-10
Decision Date2006-09-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902100033S0 K061940 000
H67902100032S0 K061940 000

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