The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Monolith Cervical Corpectomy System.
| Device ID | K180550 |
| 510k Number | K180550 |
| Device Name: | NuVasive Monolith Cervical Corpectomy System |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Martin Yahiro |
| Correspondent | Olga Lewis NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-11-20 |
| Summary: | summary |