The following data is part of a premarket notification filed by Onux Medical, Inc. with the FDA for Salute, Model 3022.
| Device ID | K014286 |
| 510k Number | K014286 |
| Device Name: | SALUTE, MODEL 3022 |
| Classification | Staple, Implantable |
| Applicant | ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842 |
| Contact | Ruthann Depietro |
| Correspondent | Ruthann Depietro ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-27 |
| Decision Date | 2002-03-08 |
| Summary: | summary |