Device Classification Name |
thoracolumbosacral pedicle screw system
|
510(k) Number |
K190408 |
Device Name |
Spinal Fixation System |
Applicant |
Shangdong Kangsheng Medical Devices Co., Ltd. |
North of Industrial Park, Dawenkou Gypsum |
Tai'an City,
CN
271000
|
|
Applicant Contact |
Wenxing Dong |
Correspondent |
Medwheat (Shanghai) Medical Technology Co. Ltd. |
Yangpu District Liaoyuan East Road Shuangyang First Suite |
No. 33 Room 303 |
Shanghai,
CN
200082
|
|
Correspondent Contact |
Jonathan Hu |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 02/21/2019 |
Decision Date | 06/16/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|