AOS Galileo™ Trochanteric Nail System

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 Aos Galileo™ Trochanteric Nail System.

Pre-market Notification Details

Device IDK202099
510k NumberK202099
Device Name:AOS Galileo™ Trochanteric Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance,  CA  90505
ContactJolie Krance
CorrespondentJolie Krance
Advanced Orthopaedic Solutions, Inc. 3203 Kashiwa Street Torrance,  CA  90505
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-29
Decision Date2020-08-28

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