Medtronic Sofamor Danek CD HORIZON® SOLERA™ Spinal System
SingaporeOrthopaedicsClass CMedtronic Sofamor Danek USA, Inc.
Official record identity
- Registration number
- DE0508620
- Model name
- 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
- 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
- Registration date
- November 01, 2023
- Source update date
- March 31, 2026
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Medtronic Sofamor Danek USA, Inc.
- Registrant / registration holder
- MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official description
Intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.
Additional source fields
- Product owner address
- 1800 Pyramid Place, Memphis, TN 38132, United States
- Registrant address
- 50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record
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.