CD Horizon Spinal System
by Medtronic Sofamor Danek USA, Inc. 8 variants
510(k) K201407
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201407 | Date10 Sep 2020 | StatusActive |
Official records
- FDA 510(k) database K201407
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- Withdrawn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
Overview
AI-generated summary, 20 Sep 2026
The CD Horizon Spinal System is a posterior spinal fixation device designed for non-cervical applications. Classified under product code NKB as an orthopedic device, it is intended for use as an adjunct to spinal fusion procedures. The system includes instrumentation components to stabilize the spine and promote proper alignment during the healing process. It is specifically engineered for lumbar and thoracic regions to address degenerative conditions requiring surgical intervention.
This system is supplied as a reusable medical device and is cleared for use in hospital operating rooms under sterile conditions. It is intended for single-patient use per surgical procedure, adhering to standard surgical protocols for spinal fixation. The device is regulated under FDA 510(k) clearance (K201407, K253335) and is classified as a Class II orthopedic device. Storage and handling follow standard medical device protocols to maintain sterility and functionality.