The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive(r) Ccx-l Interbody System.
| Device ID | K143595 |
| 510k Number | K143595 |
| Device Name: | NuVasive(R) CCX-L Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Cynthia Adams |
| Correspondent | Cynthia Adams NuVasive, Incorporated 7475 Lusk Boulevard 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 | 2014-12-18 |
| Decision Date | 2015-04-29 |
| Summary: | summary |