The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Mod-ex Xlif Interbody System.
| Device ID | K210439 |
| 510k Number | K210439 |
| Device Name: | NuVasive MOD-EX XLIF Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Manthan J. Damani |
| Correspondent | Manthan J. Damani 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 | 2021-02-12 |
| Decision Date | 2021-05-12 |