Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K191617 |
Device Name |
Syntec Tibial Nail System |
Applicant |
Syntec Scientific Corporation |
No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang |
Chang Hua,
TW
50971
|
|
Applicant Contact |
Kavin Chu |
Correspondent |
Syntec Scientific Corporation - Taipei Office |
3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., |
Taipei,
TW
10652
|
|
Correspondent Contact |
Kavin Chu |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 06/18/2019 |
Decision Date | 09/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|