Kyphoplasty systems

Calix Spinal Implant 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.

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Calix Spinal Implant System models and sizes

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

Model / catalog no.SizeMRIStatus
C034-0241β€” Not statedAvailable
C034-0242β€” Not statedAvailable
X003-0032β€” Not statedAvailable
X003-0190β€” Not statedAvailable
X003-0192β€” Not statedAvailable
X034-0880β€” Not statedAvailable
X034-0881β€” Not statedAvailable
X034-0882β€” Not statedAvailable
X034-0900β€” Not statedAvailable
X034-0905β€” Not statedAvailable
X034-0910β€” Not statedAvailable

Procedures that use kyphoplasty systems

Frequently asked questions

What is Calix Spinal Implant 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 Calix Spinal Implant System?

Calix Spinal Implant 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 Calix Spinal Implant System come in?

The FDA device database does not list sizes for Calix Spinal Implant System. Check the instructions for use or ask a Xtant Medical Holdings, Inc. representative.

Is Calix Spinal Implant System MRI safe?

The FDA device database entry for Calix Spinal Implant System does not state its MRI safety status. Check the labeling before MRI.

Is Calix Spinal Implant System FDA cleared?

Calix Spinal Implant 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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