Kyphoplasty systems
Axle Interspinous Fusion System
by Xtant Medical Holdings, Inc.
A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.
Where to buy Axle Interspinous Fusion System
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Axle Interspinous Fusion System models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| X060-0449 | — | Not stated | Available |
| X060-0450 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Axle Interspinous Fusion System used for?
A collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.
Who makes Axle Interspinous Fusion System?
Axle Interspinous Fusion System is made by Xtant Medical Holdings, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Axle Interspinous Fusion System come in?
The FDA device database does not list sizes for Axle Interspinous Fusion System. Check the instructions for use or ask a Xtant Medical Holdings, Inc. representative.
Is Axle Interspinous Fusion System MRI safe?
The FDA device database entry for Axle Interspinous Fusion System does not state its MRI safety status. Check the labeling before MRI.
Is Axle Interspinous Fusion System FDA cleared?
Axle Interspinous Fusion System is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Xtant Medical Holdings, Inc. sales representative?
Xtant Medical Holdings, Inc. has not listed representatives on LA Vascular yet. Visit the Xtant Medical Holdings, 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.