The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Humeral Nail System.
| Device ID | K161327 |
| 510k Number | K161327 |
| Device Name: | SYNTEC HUMERAL 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 509 |
| 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 | 2016-05-12 |
| Decision Date | 2017-06-08 |
| Summary: | summary |