The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Neurostructures Cavetto® [max] Cervical Cage System.
| Device ID | K181590 |
| 510k Number | K181590 |
| Device Name: | Neurostructures Cavetto® [MAX] Cervical Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | NeuroStructures, Inc. 199 Technology Drive, Suite 110 Irvine, CA 92618 |
| Contact | Kathleen Wong |
| Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2018-11-08 |
| Summary: | summary |