CD Horizon Spinal System
by Medtronic Sofamor Danek USA, Inc. 27 variants
510(k) K113174
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESU | NumberK113174 | Date21 Nov 2011 | StatusActive |
Recalls
-
- Terminated Z-2603-2018
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
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- Withdrawn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
Overview
AI-generated summary, 1 Oct 2026
The CD Horizon Spinal System is a spinal fixation device designed for internal orthopedic stabilization of the spine. It comprises pedicle screws, rods, connectors, and other instrumentation used to correct spinal deformities, stabilize fractures, or support spinal fusion procedures. The system is categorized under orthopedic fixation devices, providing mechanical support to the vertebral column to promote proper alignment and healing.
This system is supplied sterile and intended for single-use, though components may be reusable under specific reprocessing protocols as outlined by the manufacturer. It is intended for use in operating rooms and surgical settings, with components available in various sizes to accommodate different patient anatomies and clinical needs. The device is regulated under FDA 510(k) clearance (K113174) and adheres to orthopedic product standards for spinal instrumentation. Storage and handling must comply with sterile medical device protocols to ensure safety and efficacy.
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 orthopedic stabilization of the spine. It helps correct spinal deformities, stabilize fractures, and support spinal fusion procedures by providing mechanical support to the vertebral column. This promotes proper alignment and facilitates healing through secure fixation.
Is the CD Horizon Spinal System supplied sterile and for single-use?
Yes, the CD Horizon Spinal System is supplied sterile and intended for single-use. While components may be reusable under specific reprocessing protocols as outlined by Medtronic, the system is primarily engineered for one-time surgical use to ensure sterility and safety in operating room settings.
What sizes and models are available for the CD Horizon Spinal System?
The CD Horizon Spinal System includes a variety of components, such as pedicle screws, rods, and connectors, designed to accommodate different patient anatomies and clinical needs. The exact sizes and models are tailored to spinal fixation requirements, ensuring versatility for deformity correction, fracture stabilization, and fusion procedures.
How should the CD Horizon Spinal System be stored?
The CD Horizon Spinal System must be stored and handled according to sterile medical device protocols to maintain safety and efficacy. Proper storage conditions prevent contamination and ensure the device remains ready for use in surgical settings, adhering to Medtronic’s guidelines for orthopedic instrumentation.
What regulatory clearance does the CD Horizon Spinal System hold?
The CD Horizon Spinal System holds FDA 510(k) clearance under the reference number K113174. This clearance confirms that the device meets regulatory standards for spinal fixation instrumentation, ensuring its safety and performance for internal orthopedic stabilization procedures.