The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Ti-6ai-7nb Unreamed Femoral Nail.
| Device ID | K923580 |
| 510k Number | K923580 |
| Device Name: | SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-20 |
| Decision Date | 1993-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67946630S0 | K923580 | 000 |
| H67946444S0 | K923580 | 000 |
| H67946530S0 | K923580 | 000 |
| H67946632S0 | K923580 | 000 |
| H67946634S0 | K923580 | 000 |
| H67946640S0 | K923580 | 000 |
| H67946644S0 | K923580 | 000 |
| H67946648S0 | K923580 | 000 |
| H67946734S0 | K923580 | 000 |
| H67946736S0 | K923580 | 000 |
| H67946742S0 | K923580 | 000 |
| H67946744S0 | K923580 | 000 |
| H67946440S0 | K923580 | 000 |