The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Osteonics Spinal System- Rod/ Plate System.
| Device ID | K991055 |
| 510k Number | K991055 |
| Device Name: | OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Marybeth Naughton |
| Correspondent | Marybeth Naughton HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-30 |
| Decision Date | 1999-08-27 |
| Summary: | summary |