The following data is part of a premarket notification filed by Spine360 with the FDA for Talon Spinal System.
| Device ID | K102995 |
| 510k Number | K102995 |
| Device Name: | TALON SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE360 5000 PLAZA ON THE LAKE SUITE 305 Austin, TX 78746 |
| Contact | Dave Lamb |
| Correspondent | Dave Lamb SPINE360 5000 PLAZA ON THE LAKE SUITE 305 Austin, TX 78746 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-08 |
| Decision Date | 2011-02-02 |
| Summary: | summary |