CD HORIZON Spinal System
by Medtronic Sofamor Danek USA, Inc. 8 variants
510(k) K173249
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK173249 | Date8 Mar 2018 | StatusActive |
Official records
- FDA 510(k) database K173249
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- Withdrawn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, 1 Oct 2026
The CD Horizon Spinal System is a posterior spinal fixation device classified as a spinal fixation system. It is designed to provide structural support and stability to the spine as an adjunct to spinal fusion procedures, excluding cervical applications. The system includes instrumentation for securing vertebrae in alignment, aiding in the healing process of degenerative disc disease or other spinal pathologies requiring stabilization.
This system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K173249) as substantially equivalent to a predicate device, with review by the Orthopedic (OR) Advisory Committee. The device is intended for use in operating room settings and must be handled and stored according to manufacturer instructions to maintain sterility. No MRI safety information is specified in the provided data.