CD Horizon Spinal System
510(k) K211596
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK211596 | Date23 Jun 2021 | 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- Withdrawn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
- OLO
- Device class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The CD Horizon Spinal System is a spinal fixation device designed for posterior, non-cervical surgical applications. It includes rod-to-rod and screw-to-rod connectors, enabling modular construct assembly for spinal deformity correction, revision surgery, and multi-rod constructs. The system supports variable rod diameters and materials, facilitating construct extension without hardware removal. Its design is intended as an adjunct to spinal fusion procedures.
This system is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K211596) as substantially equivalent to a predicate device, with a special review classification. Components include rods, hooks, screws, and connectors in various configurations, with no specific MRI safety restrictions noted. Storage and handling follow standard surgical instrument protocols, adhering to manufacturer guidelines for sterility and surgical application.
Other devices from Medtronic, Inc.
Questions
AI-generated answers, 20 Sep 2026
What types of spinal surgeries is the CD Horizon Spinal System designed to support, and how does its modularity benefit the surgeon?
The CD Horizon Spinal System is specifically designed for posterior, non-cervical spinal surgeries, serving as an adjunct to spinal fusion procedures. Its modularity—through rod-to-rod and screw-to-rod connectors—allows surgeons to assemble customizable constructs for spinal deformity correction, revision surgeries, or multi-rod applications. This modularity enables construct extension without the need for hardware removal, reducing surgical time and potential complications while accommodating variable rod diameters and materials.
Is the CD Horizon Spinal System intended for reuse, or is it meant to be used once and then discarded?
The CD Horizon Spinal System is explicitly intended for single-use only, as stated in the manufacturer’s instructions. This design ensures patient safety and sterility, aligning with standard surgical protocols for spinal fixation devices.
What types of components are included in the CD Horizon Spinal System, and can they be mixed and matched?
The system includes rods, hooks, screws, and connectors in various configurations, allowing for modular assembly. While the components are designed to be compatible with one another, their specific mixing and matching should follow the manufacturer’s guidelines to ensure proper functionality and safety during spinal fixation procedures.
How should the CD Horizon Spinal System be stored to maintain its sterility and usability?
The system is supplied sterile, so storage must adhere to standard surgical instrument protocols to preserve sterility. The manufacturer’s guidelines should be followed for proper handling, packaging, and environmental conditions to ensure the device remains uncontaminated until use.
Are there any restrictions on using the CD Horizon Spinal System with MRI scans after implantation?
The CD Horizon Spinal System does not have specific MRI safety restrictions noted in its documentation. However, clinicians should always verify compatibility with their MRI equipment and follow the manufacturer’s instructions to ensure safe imaging post-implantation, as MRI safety can vary based on individual components and settings.