2.4MM VA-LCP INTERCARPAL FUSION SYSTEM

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 2.4mm Va-lcp Intercarpal Fusion System.

Pre-market Notification Details

Device IDK103243
510k NumberK103243
Device Name:2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactChristopher Hack
CorrespondentChristopher Hack
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 Received2010-11-01
Decision Date2011-01-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902111304100 K103243 000
H67904111300S0 K103243 000
H679041113010 K103243 000
H67904111301S0 K103243 000
H679021113000 K103243 000
H67902111300S0 K103243 000
H679021113010 K103243 000
H67902111301S0 K103243 000
H67902111304010 K103243 000
H679031110340 K103243 000
H679031110350 K103243 000
H679031110360 K103243 000
H679031110370 K103243 000
H679031110420 K103243 000
H679031110430 K103243 000
H679031110320 K103243 000
H679031110330 K103243 000
H679031110400 K103243 000
H679041113000 K103243 000

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