Kyphoplasty systems

Skyhawk

by Orthofix US LLC

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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] 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 packaged with the cage.

Ask about this device Where to buy Compare similar devices

Where to buy Skyhawk

We do not have contact details for Orthofix US LLC yet. Send a request and we will route it to the right person for your country.

Request this device

Is this your product? Claim Orthofix US LLC to list your reps and distributors by country and receive buyer requests from your territories.

Skyhawk models and sizes

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

Model / catalog no.SizeMRIStatus
27-5011— Not statedAvailable
27-5012— Not statedAvailable

Procedures that use kyphoplasty systems

Frequently asked questions

What is Skyhawk 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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] 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 packaged with the cage.

Who makes Skyhawk?

Skyhawk is made by Orthofix US LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does Skyhawk come in?

The FDA device database does not list sizes for Skyhawk. Check the instructions for use or ask a Orthofix US LLC representative.

Is Skyhawk MRI safe?

The FDA device database entry for Skyhawk does not state its MRI safety status. Check the labeling before MRI.

Is Skyhawk FDA cleared?

Skyhawk is registered in the FDA's Global Unique Device Identification Database (GUDID).

How do I contact a Orthofix US LLC sales representative?

Orthofix US LLC has not listed representatives on LA Vascular yet. Visit the Orthofix US LLC 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.

📬 The IR Device Brief

One email a month: new FDA clearances, recalls and device pages in vascular & interventional radiology.

We'll email you a link to confirm. Unsubscribe any time.

Suggest edits

For manufacturers and their teams. Each field shows what the page says now: add, remove or rewrite anything, and leave the rest as is. LA Vascular reviews every change before it goes live.

About you