SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS

Cerclage, Fixation

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 5.0mm/7.3mm Crimp Positioning Pins.

Pre-market Notification Details

Device IDK081205
510k NumberK081205
Device Name:SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS
ClassificationCerclage, Fixation
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 CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-29
Decision Date2008-07-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902221006S0 K081205 000
H67902221005S0 K081205 000
H67904221005S0 K081205 000

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