K082992 is an FDA 510(k) clearance for the AXXION LIGHT GUIDE. This device is classified as a Light, Surgical, Fiberoptic (Class II - Special Controls, product code FST).
Submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 18, 2009, 134 days after receiving the submission on October 7, 2008.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K082992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2008 |
| Decision Date | February 18, 2009 |
| Days to Decision | 134 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4580 |