Kyphoplasty systems

CD HORIZON Fenestrated Screw Set

by Medtronic Sofamor Danek, Inc.

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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CD HORIZON Fenestrated Screw Set models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
55750021540β€” Not statedAvailable
55750021545β€” Not statedAvailable
55750021550β€” Not statedAvailable
55750021555β€” Not statedAvailable
55750021560β€” Not statedAvailable
55750021565β€” Not statedAvailable
55750021570β€” Not statedAvailable
55750021575β€” Not statedAvailable
55750021580β€” Not statedAvailable
55750024530β€” Not statedAvailable
55750024535β€” Not statedAvailable
55750024540β€” Not statedAvailable
55750024545β€” Not statedAvailable
55750024550β€” Not statedAvailable
55750024555β€” Not statedAvailable
55750024560β€” Not statedAvailable
55750024565β€” Not statedAvailable
55750024570β€” Not statedAvailable
55750024575β€” Not statedAvailable
55750024580β€” Not statedAvailable
55750025530β€” Not statedAvailable
55750025535β€” Not statedAvailable
55750025540β€” Not statedAvailable
55750025545β€” Not statedAvailable
55750025550β€” Not statedAvailable
55750025555β€” Not statedAvailable
55750025560β€” Not statedAvailable
55750025565β€” Not statedAvailable
55750025570β€” Not statedAvailable
55750025575β€” Not statedAvailable
55750025580β€” Not statedAvailable
55750026530β€” Not statedAvailable
55750026535β€” Not statedAvailable
55750026540β€” Not statedAvailable
55750026545β€” Not statedAvailable
55750026550β€” Not statedAvailable
55750026555β€” Not statedAvailable
55750026560β€” Not statedAvailable
55750026565β€” Not statedAvailable
55750026570β€” Not statedAvailable
55750026575β€” Not statedAvailable
55750026580β€” Not statedAvailable
55750027530β€” Not statedAvailable
55750027535β€” Not statedAvailable
55750027540β€” Not statedAvailable
55750027545β€” Not statedAvailable
55750027550β€” Not statedAvailable
55750027555β€” Not statedAvailable
55750027560β€” Not statedAvailable
55750027565β€” Not statedAvailable
55750027570β€” Not statedAvailable
55750027575β€” Not statedAvailable
55750027580β€” Not statedAvailable
55750028530β€” Not statedAvailable
55750028535β€” Not statedAvailable
55750028540β€” Not statedAvailable
55750028545β€” Not statedAvailable
55750028550β€” Not statedAvailable
55750028555β€” Not statedAvailable
55750028560β€” Not statedAvailable
55750028565β€” Not statedAvailable
55750028570β€” Not statedAvailable
55750028575β€” Not statedAvailable
55750028580β€” Not statedAvailable
55750029540β€” Not statedAvailable
55750029545β€” Not statedAvailable
55750029550β€” Not statedAvailable
55750029555β€” Not statedAvailable
55750029560β€” Not statedAvailable
55750029565β€” Not statedAvailable
55750029570β€” Not statedAvailable
55750029575β€” Not statedAvailable
55750029580β€” Not statedAvailable
55751024530β€” Not statedAvailable
55751024535β€” Not statedAvailable
55751024540β€” Not statedAvailable
55751024545β€” Not statedAvailable
55751024550β€” Not statedAvailable
55751024555β€” Not statedAvailable
55751024560β€” Not statedAvailable
55751024565β€” Not statedAvailable
55751024570β€” Not statedAvailable
55751024575β€” Not statedAvailable
55751024580β€” Not statedAvailable
55751025030β€” Not statedAvailable
55751025035β€” Not statedAvailable
55751025040β€” Not statedAvailable
55751025045β€” Not statedAvailable
55751025050β€” Not statedAvailable
55751025055β€” Not statedAvailable
55751025060β€” Not statedAvailable
55751025065β€” Not statedAvailable
55751025070β€” Not statedAvailable
55751025075β€” Not statedAvailable
55751025080β€” Not statedAvailable
55751025530β€” Not statedAvailable
55751025535β€” Not statedAvailable
55751025540β€” Not statedAvailable
55751025545β€” Not statedAvailable
55751025550β€” Not statedAvailable
55751025555β€” Not statedAvailable
55751025560β€” Not statedAvailable
55751025565β€” Not statedAvailable
55751025570β€” Not statedAvailable
55751025575β€” Not statedAvailable
55751025580β€” Not statedAvailable
55751026530β€” Not statedAvailable
55751026535β€” Not statedAvailable
55751026540β€” Not statedAvailable
55751026545β€” Not statedAvailable
55751026550β€” Not statedAvailable
55751026555β€” Not statedAvailable
55751026560β€” Not statedAvailable
55751026565β€” Not statedAvailable
55751026570β€” Not statedAvailable
55751026575β€” Not statedAvailable
55751026580β€” Not statedAvailable
55751027530β€” Not statedAvailable
55751027535β€” Not statedAvailable
55751027540β€” Not statedAvailable
55751027545β€” Not statedAvailable
55751027550β€” Not statedAvailable
55751027555β€” Not statedAvailable
55751027560β€” Not statedAvailable
55751027565β€” Not statedAvailable
55751027570β€” Not statedAvailable
55751027575β€” Not statedAvailable
55751027580β€” Not statedAvailable
55851024530β€” Not statedAvailable
55851024535β€” Not statedAvailable
55851024540β€” Not statedAvailable
55851024545β€” Not statedAvailable
55851024550β€” Not statedAvailable
55851024555β€” Not statedAvailable
55851024560β€” Not statedAvailable
55851024565β€” Not statedAvailable
55851024570β€” Not statedAvailable
55851024575β€” Not statedAvailable
55851024580β€” Not statedAvailable
55851025030β€” Not statedAvailable
55851025035β€” Not statedAvailable
55851025040β€” Not statedAvailable
55851025045β€” Not statedAvailable
55851025050β€” Not statedAvailable
55851025055β€” Not statedAvailable
55851025060β€” Not statedAvailable
55851025065β€” Not statedAvailable
55851025070β€” Not statedAvailable
55851025075β€” Not statedAvailable
55851025080β€” Not statedAvailable
55851025530β€” Not statedAvailable
55851025535β€” Not statedAvailable
55851025540β€” Not statedAvailable
55851025545β€” Not statedAvailable
55851025550β€” Not statedAvailable
55851025555β€” Not statedAvailable
55851025560β€” Not statedAvailable
55851025565β€” Not statedAvailable
55851025570β€” Not statedAvailable
55851025575β€” Not statedAvailable
55851025580β€” Not statedAvailable
55851026530β€” Not statedAvailable
55851026535β€” Not statedAvailable
55851026540β€” Not statedAvailable
55851026545β€” Not statedAvailable
55851026550β€” Not statedAvailable
55851026555β€” Not statedAvailable
55851026560β€” Not statedAvailable
55851026565β€” Not statedAvailable
55851026570β€” Not statedAvailable
55851026575β€” Not statedAvailable
55851026580β€” Not statedAvailable
55851027530β€” Not statedAvailable
55851027535β€” Not statedAvailable
55851027540β€” Not statedAvailable
55851027545β€” Not statedAvailable
55851027550β€” Not statedAvailable
55851027555β€” Not statedAvailable
55851027560β€” Not statedAvailable
55851027565β€” Not statedAvailable
55851027570β€” Not statedAvailable
55851027575β€” Not statedAvailable
55851027580β€” Not statedAvailable

FDA clearances

  • 510(k) K201362 August 2020

Procedures that use kyphoplasty systems

Frequently asked questions

What is CD HORIZON Fenestrated Screw Set used for?

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Who makes CD HORIZON Fenestrated Screw Set?

CD HORIZON Fenestrated Screw Set is made by Medtronic Sofamor Danek, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does CD HORIZON Fenestrated Screw Set come in?

The FDA device database does not list sizes for CD HORIZON Fenestrated Screw Set. Check the instructions for use or ask a Medtronic Sofamor Danek, Inc. representative.

Is CD HORIZON Fenestrated Screw Set MRI safe?

The FDA device database entry for CD HORIZON Fenestrated Screw Set does not state its MRI safety status. Check the labeling before MRI.

Is CD HORIZON Fenestrated Screw Set FDA cleared?

CD HORIZON Fenestrated Screw Set is covered by FDA submission K201362.

How do I contact a Medtronic Sofamor Danek, Inc. sales representative?

Medtronic Sofamor Danek, Inc. has not listed representatives on LA Vascular yet. Visit the Medtronic Sofamor Danek, Inc. company page for contact details.

Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.

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