SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 2.4 Mm/2.7 Mm Variable Angle Lcp Forefoot/midfoot System.

Pre-market Notification Details

Device IDK100776
510k NumberK100776
Device Name:SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
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 Received2010-03-18
Decision Date2010-08-03
Summary:summary

NIH GUDID Devices

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