The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Universal Tibial Nail And Unreamed Tibial Nail.
| Device ID | K914453 |
| 510k Number | K914453 |
| Device Name: | UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL |
| Classification | Nail, Fixation, Bone |
| 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 | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-04 |
| Decision Date | 1992-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679458800 | K914453 | 000 |
| H679458780 | K914453 | 000 |
| H679458760 | K914453 | 000 |
| H679458740 | K914453 | 000 |
| H679458720 | K914453 | 000 |
| H679458700 | K914453 | 000 |
| H679458680 | K914453 | 000 |
| H679458660 | K914453 | 000 |