The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Nuvaline.
| Device ID | K192435 |
| 510k Number | K192435 |
| Device Name: | NuVasive NuvaLine |
| Classification | System, Image Processing, Radiological |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Manthan Damani |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-09-05 |
| Decision Date | 2019-09-26 |
| Summary: | summary |