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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K143204
Device Name AOS Clavicle Intramedullary Device
Applicant
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Applicant Contact ANNA HWANG
Correspondent
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa St.
Torrance,  CA  90505
Correspondent Contact ANNA HWANG
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Code
JDW  
Date Received11/07/2014
Decision Date 06/03/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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