Lexus Cervical Fixation System
510(k) K120879
Lexus Cervical Fixation System is a Class II device made by L&K Biomed Co., Ltd., cleared under FDA 510(k) K120879 on 23 May 2012, 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 | NumberK120879 | Date23 May 2012 | StatusActive |
Official records
- FDA 510(k) database K120879
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent