The following data is part of a premarket notification filed by Spine 360 with the FDA for Spine360 Anterior Cervical Plate System.
| Device ID | K092531 |
| 510k Number | K092531 |
| Device Name: | SPINE360 ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINE 360 5000 PLAZA ON THE LAKE SUITE 305 Austin, TX 78746 |
| Contact | Joshua Kaufmann |
| Correspondent | Joshua Kaufmann SPINE 360 5000 PLAZA ON THE LAKE SUITE 305 Austin, TX 78746 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-18 |
| Decision Date | 2010-02-04 |
| Summary: | summary |