Focus Spinal System
510(k) K120140
Focus Spinal System is a Class II device made by L&K Biomed Co., Ltd., cleared under FDA 510(k) K120140 on 15 Feb 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 | NumberK120140 | Date15 Feb 2012 | StatusActive |
Official records
- FDA 510(k) database K120140
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
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