Lucent
by Spinal Elements, Inc. 2 variants
510(k) K122967
Lucent is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K122967 on 21 Feb 2013, 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 | NumberK122967 | Date21 Feb 2013 | StatusActive |
Official records
- FDA 510(k) database K122967
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent