The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cortina [max] Lumbar Cage System.
| Device ID | K180431 |
| 510k Number | K180431 |
| Device Name: | Cortina [MAX] Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | NeuroStructures, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 |
| Contact | Kathleen Wong |
| Correspondent | Kathleen Wong NeuroStructures, Inc. 16 Technology Drive, Suite 165 Irvine, CA 92618 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-16 |
| Decision Date | 2018-03-22 |
| Summary: | summary |