The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Spinal System 5.5mm & 10.0mm Bone Screws.
| Device ID | K983152 |
| 510k Number | K983152 |
| Device Name: | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM 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 | 1998-09-09 |
| Decision Date | 1998-09-25 |
| Summary: | summary |