FDA 510(k) Application Details - K200491

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K200491
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	Aike (Shanghai) Medical Instrument Co., Ltd. B320, B321, B322, B323, No. 1128, South Huicheng Road, Jiading Industrial Shanghai 201801 CN Other 510(k) Applications for this Company
Contact	Gu Hongying Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/28/2020
Decision Date	01/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review