AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON

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

ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

The following data is part of a premarket notification filed by Advanced Orthopaedic Solutions, Inc. with the FDA for Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon.

Pre-market Notification Details

Device IDK141912
510k NumberK141912
Device Name:AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance,  CA  90505
ContactAnna Hwang
CorrespondentAnna Hwang
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. 3203 KASHIWA STREET Torrance,  CA  90505
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-15
Decision Date2014-10-29
Summary:summary

NIH GUDID Devices

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