Singapore HSA registration DE0510084
Medtronic CD HORIZON® SOLERA® Spinal System – Tapered and Apex Rods
Singapore·CLASS C·Medtronic Sofamor Danek USA, Inc.·Registered November 28, 2024Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0510084
- Registration Date
- November 28, 2024
- Retention Due Date
- November 27, 2025
Product description
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
- Short Name
- Medtronic Sofamor Danek USA, Inc.
- Address
- 1800 Pyramid Place, Memphis, Tennessee 38132, UNITED STATES
Registrant
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
- Address
- 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model information
- Model Name(s)
- 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(s)
- 1546000500 1546000600 1556009500 1556009600 1606009500 1606009600 1636009600 1656000500 1656000600
About this record
Access comprehensive regulatory information for Medtronic CD HORIZON® SOLERA® Spinal System – Tapered and Apex Rods in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510084 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on November 28, 2024.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C