The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cavetto-sa Cervical Cage System.
| Device ID | K200115 |
| 510k Number | K200115 |
| Device Name: | Cavetto-SA Cervical Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | NeuroStructures, Inc. 199 Technology Drive, Suite 110 Irvine, CA 92618 |
| Contact | Moti Altarac |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-21 |
| Decision Date | 2020-09-24 |