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Medtronic Sofamor Danek CD HORIZON® SOLERA™ Spinal System - HSA Registration DE0508620

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.

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CLASS C
DE0508620
Medtronic Sofamor Danek CD HORIZON® SOLERA™ Spinal System
HSA Registration Number: DE0508620
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Product Description

Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.

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 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