OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL

Rod, Fixation, Intramedullary And Accessories

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo Ic Retrograde/antegrade Femoral Nail.

Pre-market Notification Details

Device IDK982601
510k NumberK982601
Device Name:OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactKate Sutton
CorrespondentKate Sutton
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-27
Decision Date1998-09-14
Summary:summary

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