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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, multiple component
510(k) Number K200491
Device Name Bfix Orthopedic External Fixator Systems
Applicant
Aike (Shanghai) Medical Instrument Co., Ltd.
B320, B321, B322, B323, No. 1128, South Huicheng Road,
Jiading Industrial
Shanghai,  CN 201801
Applicant Contact Gu Hongying
Correspondent
Shanghai Landlink Medical Information Technology Co., Ltd.
B320,B321,B322, B323,No. 1128, South Huicheng Road
Shanghai,  CN 200071
Correspondent Contact Hongying Gu
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received02/28/2020
Decision Date 01/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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