The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Mlx-medial Lateral Expandable Lumbar Interbody System, Nuvasive Ap Expandable Xlif System.
| Device ID | K151374 |
| 510k Number | K151374 |
| Device Name: | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Boulevard San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis 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 | 2015-05-22 |
| Decision Date | 2015-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517210173 | K151374 | 000 |