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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K202489
Device Name AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System
Applicant
Advanced Orthopaedic Solutions, Inc.
3203 Kashiwa Street
Torrance,  CA  90505
Applicant Contact Jolie Krance
Correspondent
Advanced Orthopaedic Solutions
3203 Kashiwa Street
Torrance,  CA  90505
Correspondent Contact Jolie Krance
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/31/2020
Decision Date 10/26/2020
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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