The following data is part of a premarket notification filed by Spinal Elements, Inc. with the FDA for Axxion Light Guide.
| Device ID | K082992 |
| 510k Number | K082992 |
| Device Name: | AXXION LIGHT GUIDE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Contact | Kerri Dimartino |
| Correspondent | Kerri Dimartino SPINAL ELEMENTS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92010 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-07 |
| Decision Date | 2009-02-18 |
| Summary: | summary |