HSA · registration DE0510084Medtronic CD HORIZON® SOLERA® Spinal System – Tapered and Apex Rods
- Registration number
- DE0510084
- Model name
- CD HORIZON® Spinal System Tapered Rod; CD HORIZON® Spinal System Tapered Rod; CD HORIZON® Spinal System Apex Rod; CD HORIZON® Spinal System Apex Rod; CD HORIZON® Spinal System Apex Rod; CD HORIZON® Spinal System Apex Rod; CD HORIZON® Spinal System Apex Rod; CD HORIZON® Spinal System Tapered Rod; CD HORIZON® Spinal System Tapered Rod
- Model identifier
- 1546000500; 1546000600; 1556009500; 1556009600; 1606009500; 1606009600; 1636009600; 1656000500; 1656000600
- Registration date
- November 28, 2024
- Source update date
- January 09, 2026
- Risk class
- Class C
- Product owner
- Medtronic Sofamor Danek USA, Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
- Product owner address
- 1800 Pyramid Place, Memphis, Tennessee 38132, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.