The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Brigade Lateral System.
| Device ID | K181386 |
| 510k Number | K181386 |
| Device Name: | NuVasive Brigade Lateral System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Jessica Silverman |
| Correspondent | Jessica Silverman NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-25 |
| Decision Date | 2018-08-24 |