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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
510(k) Number K160409
Device Name AOS Anterolateral Proximal Humeral Plate
Applicant
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Applicant Contact KAZU MIYAHARA
Correspondent
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact KAZU MIYAHARA
Regulation Number888.3030
Classification Product Code
KTW  
Date Received02/16/2016
Decision Date 03/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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