The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Cohere Alif System Intervertebral Body Fusion Device.
| Device ID | K221751 |
| 510k Number | K221751 |
| Device Name: | NuVasive Cohere ALIF System Intervertebral Body Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Jessica LeBlanc |
| Correspondent | Jessica LeBlanc NuVasive, Incorporated 7475 Lusk Boulevard 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 | 2022-06-16 |
| Decision Date | 2022-10-21 |