The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Thoracolumbar Interbody Systems: Coroent Thoracolumbar System, Coroent Xl Interfixated System, Brigade Standalone System And Brigade Hyperlordotic System, Brigade Lateral System, Base Interfixated Titanium System, Coalesce Thoracolumbar Inte.
| Device ID | K201820 |
| 510k Number | K201820 |
| Device Name: | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System And Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Inte |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd San Diego, CA 92121 |
| Contact | Daniela Mahan |
| Correspondent | Daniela Mahan NuVasive, Incorporated 7475 Lusk Blvd San Diego, CA 92121 |
| Product Code | MAX |
| Subsequent Product Code | OVD |
| Subsequent Product Code | PHM |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-01 |
| Decision Date | 2020-09-25 |