SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Multiloc Proximal Humeral Nailing System.

Pre-market Notification Details

Device IDK103002
510k NumberK103002
Device Name:SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
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 CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-08
Decision Date2011-03-02
Summary:summary

NIH GUDID Devices

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