ANTEGRADE FEMORAL NAIL

Rod, Fixation, Intramedullary And Accessories

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Antegrade Femoral Nail.

Pre-market Notification Details

Device IDK123569
510k NumberK123569
Device Name:ANTEGRADE FEMORAL NAIL
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance,  CA  90501
ContactJulie Glendrange
CorrespondentJulie Glendrange
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 386 BEECH AVENUE UNIT B6 Torrance,  CA  90501
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-20
Decision Date2013-05-24
Summary:summary

NIH GUDID Devices

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