Lucent Magnum
by Spinal Elements, Inc. 2 variants
510(k) K083475
Lucent Magnum is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K083475 on 13 Feb 2009, active as of 22 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 | NumberK083475 | Date13 Feb 2009 | StatusActive |
Official records
- FDA 510(k) database K083475
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVD
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent