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 |
|