The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteo Ic Retrograde/antegrade Femoral Nail.
| Device ID | K982601 |
| 510k Number | K982601 |
| Device Name: | OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-27 |
| Decision Date | 1998-09-14 |
| Summary: | summary |