The following data is part of a premarket notification filed by Neurostructures with the FDA for Oculus-sa Lumbar Cage System.
| Device ID | K202190 |
| 510k Number | K202190 |
| Device Name: | Oculus-SA Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Neurostructures 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 | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-05 |
| Decision Date | 2020-10-02 |