The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Small Orthopedic Fixation System, Model 71100, 294-300,400 & 292-730/820.
| Device ID | K984364 |
| 510k Number | K984364 |
| Device Name: | SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| 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 | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1999-03-02 |
| Summary: | summary |