The following data is part of a premarket notification filed by Nuvasive, Inc. with the FDA for Nuvasive Spinal System.
| Device ID | K033546 |
| 510k Number | K033546 |
| Device Name: | NUVASIVE SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Contact | Laetitia Bernard |
| Correspondent | Laetitia Bernard NUVASIVE, INC. 10065 OLD GROVE RD. San Diego, CA 92131 |
| Product Code | MNH |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-12 |
| Decision Date | 2004-04-12 |
| Summary: | summary |