The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Opus Spinal System.
| Device ID | K993402 |
| 510k Number | K993402 |
| Device Name: | OPUS SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Mary-catherine Dillon |
| Correspondent | Mary-catherine Dillon HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-08 |
| Decision Date | 1999-12-20 |
| Summary: | summary |