The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Lessray With Enhanced Tracking.
| Device ID | K170800 |
| 510k Number | K170800 |
| Device Name: | NuVasive LessRay With Enhanced Tracking |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Manthan J. Damani |
| Correspondent | Manthan J. Damani NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-17 |
| Decision Date | 2017-08-18 |
| Summary: | summary |