Kyphoplasty systems

Irix-A Lumbar Integrated Fusion System

by Xtant Medical Holdings, Inc.

A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.

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Irix-A Lumbar 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.SizeMRIStatus
T080-0020— Not statedAvailable
T080-0025— Not statedAvailable

Procedures that use kyphoplasty systems

Frequently asked questions

What is Irix-A Lumbar Integrated Fusion System used for?

A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device.

Who makes Irix-A Lumbar Integrated Fusion System?

Irix-A Lumbar 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-A Lumbar Integrated Fusion System come in?

The FDA device database does not list sizes for Irix-A Lumbar Integrated Fusion System. Check the instructions for use or ask a Xtant Medical Holdings, Inc. representative.

Is Irix-A Lumbar Integrated Fusion System MRI safe?

The FDA device database entry for Irix-A Lumbar Integrated Fusion System does not state its MRI safety status. Check the labeling before MRI.

Is Irix-A Lumbar Integrated Fusion System FDA cleared?

Irix-A Lumbar 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.

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