The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Mlx™ - Medial Lateral Expandable Lumbar Interbody System.
| Device ID | K153105 |
| 510k Number | K153105 |
| Device Name: | MLX™ - Medial Lateral Expandable Lumbar Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NuVasive, Incorporated 7475 Lusk Blvd. San Diego, CA 92121 |
| Contact | Olga Lewis |
| Correspondent | Cynthia Adams 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 | 2015-10-27 |
| Decision Date | 2016-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517498274 | K153105 | 000 |
| 00887517700117 | K153105 | 000 |
| 00887517700124 | K153105 | 000 |
| 00887517700131 | K153105 | 000 |
| 00887517700148 | K153105 | 000 |
| 00887517700155 | K153105 | 000 |
| 00887517700162 | K153105 | 000 |
| 00887517729293 | K153105 | 000 |
| 00887517732613 | K153105 | 000 |
| 00887517732637 | K153105 | 000 |
| 00887517498137 | K153105 | 000 |
| 00887517498250 | K153105 | 000 |
| 00887517498267 | K153105 | 000 |
| 00887517700100 | K153105 | 000 |