The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Spinal System-expanded Indications.
| Device ID | K990059 |
| 510k Number | K990059 |
| Device Name: | OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Kate Sutton |
| Correspondent | Kate Sutton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-08 |
| Decision Date | 1999-01-28 |
| Summary: | summary |