The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Coroent Thoracolumbar System.
| Device ID | K153419 |
| 510k Number | K153419 |
| Device Name: | NuVasive CoRoent Thoracolumbar System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Contact | Michelle Cheung |
| Correspondent | Michelle Cheung NUVASIVE, INCORPORATED 7475 LUSK BLVD. San Diego, CA 92121 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-04-13 |
| Summary: | summary |