Lucent®
510(k) K170235
Lucent® is a Class II device made by Spinal Elements, Inc., cleared under FDA 510(k) K170235 on 29 Nov 2017, 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 | NumberK170235 | Date29 Nov 2017 | StatusActive |
Official records
- FDA 510(k) database K170235
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- Withdrawn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