T2 RECON NAIL SYSTEM

Rod, Fixation, Intramedullary And Accessories

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for T2 Recon Nail System.

Pre-market Notification Details

Device IDK051624
510k NumberK051624
Device Name:T2 RECON NAIL SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactVivian Kelly
CorrespondentVivian Kelly
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-20
Decision Date2005-07-07
Summary:summary

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