The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Tibial Tray Screw Hole Plugs.
| Device ID | K970779 |
| 510k Number | K970779 |
| Device Name: | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS |
| Classification | Cement Obturator |
| 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 | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-05-09 |
| Summary: | summary |