The following data is part of a premarket notification filed by Syntec Scientific Corporation with the FDA for Syntec Non-sterile Steinmann Pins System.
| Device ID | K200933 |
| 510k Number | K200933 |
| Device Name: | Syntec Non-Sterile Steinmann Pins System |
| Classification | Pin, Fixation, Threaded |
| Applicant | Syntec Scientific Corporation No.2, Kung San Road Chuan Shing Industrial Zone, Shen Kang Chang Hua, TW 50971 |
| Contact | Nicole Tseng |
| Correspondent | Nicole Tseng Syntec Scientific Corporation - Taipei Office 3F., No.96, Sec. 3, Zhongxio East Road Da'An Dist., Taipei, TW 10652 |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-07 |
| Decision Date | 2020-05-05 |