Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K172267 |
Device Name |
IRENE Thoracolumbar Fixation System |
Applicant |
Tianjin Zhengtian Medical Instrument Co.,Ltd. |
No. 318, Jingyi Road, Airport Economic Zone |
Tianjin,
CN
300308
|
|
Applicant Contact |
Ou Changli |
Correspondent |
Tianjin Zhengtian Medical Instrument Co.,Ltd. |
No. 318, Jingyi Road, Airport Economic Zone |
Tianjin,
CN
300308
|
|
Correspondent Contact |
Changli Ou |
Regulation Number | 888.3070
|
Classification Product Code |
|
Date Received | 07/27/2017 |
Decision Date | 03/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|