Kyphoplasty systems
Irix-C Cervical Integrated Fusion System
by Xtant Medical Holdings, Inc.
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Where to buy Irix-C Cervical Integrated Fusion System
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Irix-C Cervical Integrated 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 |
|---|---|---|---|
| T066-0190 | — | Not stated | Available |
| T066-0225 | — | Not stated | Available |
| T066-0230 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Irix-C Cervical Integrated Fusion System used for?
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.
Who makes Irix-C Cervical Integrated Fusion System?
Irix-C Cervical Integrated 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 Irix-C Cervical Integrated Fusion System come in?
The FDA device database does not list sizes for Irix-C Cervical Integrated Fusion System. Check the instructions for use or ask a Xtant Medical Holdings, Inc. representative.
Is Irix-C Cervical Integrated Fusion System MRI safe?
The FDA device database entry for Irix-C Cervical Integrated Fusion System does not state its MRI safety status. Check the labeling before MRI.
Is Irix-C Cervical Integrated Fusion System FDA cleared?
Irix-C Cervical Integrated 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.