The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Tibial Nail System.
| Device ID | K191617 |
| 510k Number | K191617 |
| Device Name: | Syntec Tibial Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Syntec Scientific Corporation No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang Chang Hua, TW 50971 |
| Contact | Kavin Chu |
| Correspondent | Kavin Chu Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, TW 10652 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-09-03 |
| Summary: | summary |