The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Combination Screw Ring/blocker.
| Device ID | K990158 |
| 510k Number | K990158 |
| Device Name: | OSTEONICS COMBINATION SCREW RING/BLOCKER |
| Classification | Orthosis, Spinal Pedicle 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 | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-02-01 |
| Summary: | summary |