The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Oct System.
| Device ID | K071435 |
| 510k Number | K071435 |
| Device Name: | NUVASIVE OCT SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Contact | Laetitia Cousin |
| Correspondent | Laetitia Cousin NUVASIVE, INC. 4545 TOWNE CENTRE COURT San Diego, CA 92121 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-23 |
| Decision Date | 2007-08-06 |
| Summary: | summary |