Singapore HSA registration DE0508620
Medtronic Sofamor Danek CD HORIZON® SOLERA™ Spinal System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Orthopaedics
Registration information
- Registration Number
- DE0508620
- Registration Date
- November 01, 2023
- Retention Due Date
- October 31, 2025
Product description
Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.
Product Owner
- Short Name
- Medtronic Sofamor Danek USA, Inc.
- Address
- 1800 Pyramid Place, Memphis, TN 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)
- CHROMALOY™ PLUS ROD Variable Angle Domino Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS HA COATED MULTI-AXIAL SCREW FOR 5.5/6.0mm RODS Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load Lateral Connector Top Load
- Model Identifier(s)
- 1556000500 5135251 5554320 5554325 5554330 5554335 5554340 5554345 5554350 5554355 5554360 5564320 5564325 5564330 5564335 5564340 5564345 5564350 5564355 5564360 5564370 55740105530 55740105535 55740105540 55740105545 55740105550 55740106530 55740106535 55740106540 55740106545 55740106550 55740106555 55740107530 55740107535 55740107540 55740107545 55740107550 55740107555 55740108535 55740108540 55740108545 55740108550 55740108555 5764320 5764325 5764330 5764335 5764340 5764345 5764350 5764355 5764360
About this record
Access comprehensive regulatory information for Medtronic Sofamor Danek CD HORIZON® SOLERA™ Spinal System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508620 and owned by Medtronic Sofamor Danek USA, Inc.. The device was registered on November 01, 2023.
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