HSA · registration DE0508522

Medtronic CD HORIZON™ Spinal System

Name: Medtronic CD HORIZON™ Spinal System — HSA DE0508522
Creator: Medtronic Sofamor Danek USA, Inc.
Keywords: Medtronic CD HORIZON™ Spinal System, Medtronic CD HORIZON™ Spinal System, DE0508522, Orthopaedics, HSA

SingaporeOrthopaedicsClass CMedtronic Sofamor Danek USA, Inc.

Verified

Official record identity

Registration number: DE0508522
Model name: 19MM ROSTRAL STAPLE, TI; 21MM ROSTRAL STAPLE, TI; 23MM ROSTRAL STAPLE, TI; 25MM ROSTRAL STAPLE, TI; 19MM CAUDAL STAPLE, TI; 21MM CAUDAL STAPLE, TI; 23MM CAUDAL STAPLE, TI; 25MM CAUDAL STAPLE, TI; STAPLE, SINGLE, 13MM, TI; STAPLE, SINGLE, 15MM, TI; STAPLE, SINGLE, 17MM, TI; 5.5MM FAS FOR Ø5.5 ROD, TI - 20MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 25MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 30MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 35MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 40MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 45MM LG; 5.5MM FAS FOR Ø5.5 ROD, TI - 50MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 20MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 25MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 30MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 35MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 40MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 45MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 50MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 55MM LG; 6.5MM FAS FOR Ø5.5 ROD, TI - 60MM LG; ANTERIOR CROSSLINK, 13MM; ANTERIOR CROSSLINK, 14MM; ANTERIOR CROSSLINK, 15MM; ANTERIOR CROSSLINK, 16MM; ANTERIOR CROSSLINK, 17MM; ANTERIOR CROSSLINK, 18MM; ANTERIOR CROSSLINK, 19MM; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD; 5.5MM PRE-CUT CP TI ROD
Model identifier: 6541019; 6541021; 6541023; 6541025; 6541119; 6541121; 6541123; 6541125; 6541213; 6541215; 6541217; 6543520; 6543525; 6543530; 6543535; 6543540; 6543545; 6543550; 6543620; 6543625; 6543630; 6543635; 6543640; 6543645; 6543650; 6543655; 6543660; 8110713; 8110714; 8110715; 8110716; 8110717; 8110718; 8110719; 8699050; 8699055; 8699060; 8699065; 8699070; 8699075; 8699080; 8699085; 8699090; 8699095; 8699100
Registration date: September 27, 2023
Source update date: April 27, 2026

Classification

Risk class: Class C
Published category: Orthopaedics

Published parties

Product owner: Medtronic Sofamor Danek USA, Inc.
Registrant / registration holder: MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)

Official 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 (DDD - 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. Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion.

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.