The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Ti-6al-7nb Urtn.
| Device ID | K932330 |
| 510k Number | K932330 |
| Device Name: | TI-6AL-7NB URTN |
| 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 | 1993-05-13 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679458100 | K932330 | 000 |
| H67947836S0 | K932330 | 000 |
| H67947834S0 | K932330 | 000 |
| H67947833S0 | K932330 | 000 |
| H67947831S0 | K932330 | 000 |
| H67947827S0 | K932330 | 000 |