The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Transept Cervical Plate System.
| Device ID | K200927 |
| 510k Number | K200927 |
| Device Name: | Transept Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Neurostructures, Inc. 199 Technology Dr. Suite 110 Irvine, CA 92618 |
| Contact | Moti Altarac |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-07 |
| Decision Date | 2020-07-24 |