Cd Horizon Spinal System
by Medtronic Sofamor Danek USA, Inc. 27 variants
510(k) K130646
Cd Horizon Spinal System is a Class II device made by Medtronic Sofamor Danek USA, Inc., cleared under FDA 510(k) K130646 on 10 Apr 2013, 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)SESU | NumberK130646 | Date10 Apr 2013 | StatusActive |
Official records
- FDA 510(k) database K130646
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- Withdrawn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
- SESU