The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Titanium Alloy Mini-plate.
| Device ID | K983988 |
| 510k Number | K983988 |
| Device Name: | SYNTEC-TAICHUNG NON-STERILE TITANIUM ALLOY MINI-PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Contact | Ted Y Shi |
| Correspondent | Ted Y Shi SYNTEC SCIENTIFIC CORP. 2, KUNG SAN ROAD, CHAUN SHING INDUSTRIAL ZONE, SHEN KANG Chang Hua, TW 509 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1999-01-27 |
| Summary: | summary |