The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Spinal System Cylindrical Bone Screws.
| Device ID | K984302 |
| 510k Number | K984302 |
| Device Name: | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| 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 | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-02 |
| Decision Date | 1998-12-18 |
| Summary: | summary |