Axxion Light Guide
510(k) K082992
Axxion Light Guide is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K082992 on 18 Feb 2009, active as of 11 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082992 | Date18 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K082992
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- FST
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4580
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
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