The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Anterior Cervical Compression Plating System.
| Device ID | K982798 |
| 510k Number | K982798 |
| Device Name: | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-10 |
| Decision Date | 1999-03-25 |
| Summary: | summary |