AOS Anterolateral Proximal Humeral Plate

Appliance, Fixation, Nail/blade/plate Combination, Single Component

Advanced Orthopaedic Solutions, Inc. (AOS)

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. (aos) with the FDA for Aos Anterolateral Proximal Humeral Plate.

Pre-market Notification Details

Device IDK171606
510k NumberK171606
Device Name:AOS Anterolateral Proximal Humeral Plate
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Single Component
Applicant Advanced Orthopaedic Solutions, Inc. (AOS) 3203 Kashiwa Street Torrance,  CA  90505
ContactAlex Bhaskarla
CorrespondentAlex Bhaskarla
Advanced Orthopaedic Solutions, Inc. (AOS) 3203 Kashiwa Street Torrance,  CA  90505
Product CodeKTW  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-06-01
Decision Date2017-06-22
Summary:summary

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