Venus Cervical Spinal Fixation System
510(k) K103414
Venus Cervical Spinal Fixation System is a Class II device made by L&K Biomed Co., Ltd., cleared under FDA 510(k) K103414 on 22 Jul 2011, 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 | NumberK103414 | Date22 Jul 2011 | StatusActive |
Official records
- FDA 510(k) database K103414
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- Withdrawn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