The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec Os Spinal Fixation System.
| Device ID | K101971 |
| 510k Number | K101971 |
| Device Name: | SYNTEC OS SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHUAN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Contact | Carol Chang |
| Correspondent | Carol Chang SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHUAN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-13 |
| Decision Date | 2011-03-25 |
| Summary: | summary |