LUX Expandable Lumbar Interbody System
510(k) K253583
LUX Expandable Lumbar Interbody System is a Class II device made by Xenix Medical, cleared under FDA 510(k) K253583 on 23 Feb 2026, 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 | NumberK253583 | Date23 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K253583
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- Withdrawn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