CD Horizon Spinal System
by Medtronic Sofamor Danek, Inc. 29 variants
510(k) K014296
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK014296 | Date10 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KWP
- FDA applicant
- Medtronic Sofamor Danek
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The CD Horizon Spinal System is an orthopedic spinal fixation device designed for internal stabilization of the spine. It includes rods, hooks, screws, plates, staples, and connecting components that can be rigidly locked into various configurations to address spinal deformities or instability, facilitating spinal fusion procedures.
This system is supplied as a modular assembly of reusable and single-use components, tailored for surgical use in spinal stabilization procedures. Components are intended for use in MRI-unsafe environments, and the system is authorized under FDA 510(k) clearance (K014296) for orthopedic applications. Sterility and packaging details are not specified in the provided data.
Other devices from Medtronic Sofamor Danek, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the CD Horizon Spinal System used for?
The CD Horizon Spinal System is designed for internal spinal stabilization during surgical procedures. It provides rigid fixation to address spinal deformities or instability, supporting spinal fusion by securing rods, hooks, screws, plates, and connecting components in customizable configurations. This modular approach allows surgeons to tailor the system to specific anatomical needs, ensuring secure alignment and support during recovery.
How are the components of the CD Horizon Spinal System supplied?
The system is supplied as a modular assembly combining both reusable and single-use components. This design allows for flexibility in surgical planning, enabling the selection of specific parts based on the patient’s anatomy and clinical requirements. The modularity also facilitates efficient use of inventory and reduces waste by enabling reuse of compatible components where applicable.
Is the CD Horizon Spinal System suitable for MRI environments?
No, the CD Horizon Spinal System is intended for use in MRI-unsafe environments. The materials and components of this system are not designed to be MRI-compatible, meaning they should not be used in procedures or settings where MRI imaging is required or performed. Always verify the environment’s safety protocols before use.
Are all components of the CD Horizon Spinal System single-use?
The system includes both reusable and single-use components. While some parts may be designed for single-use to ensure sterility and safety, others are reusable, allowing for cost-effective use across multiple procedures. The manufacturer’s instructions should be consulted to determine the specific reuse or single-use designation for each component in the assembly.
What regulatory clearance does the CD Horizon Spinal System hold?
The CD Horizon Spinal System holds FDA 510(k) clearance under the reference number K014296. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting the regulatory requirements for safety and effectiveness in orthopedic spinal fixation applications. Always refer to the latest regulatory documentation for current status.