The following data is part of a premarket notification filed by Syntec Scientific Corp. with the FDA for Syntec-taichung Non-sterile Interlocking Nail System, Model:humerus:256-000/280, Femur:274-000/870, Tibia:249-300/420 25.
| Device ID | K984543 |
| 510k Number | K984543 |
| Device Name: | SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM, MODEL:HUMERUS:256-000/280, FEMUR:274-000/870, TIBIA:249-300/420 25 |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| 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 | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-03-01 |
| Summary: | summary |