Kyphoplasty systems
Navagio
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Where to buy Navagio
We do not have contact details for Kalitec Direct LLC yet. Send a request and we will route it to the right person for your country.
Navagio 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 |
|---|---|---|---|
| 30-K01-6010 | — | Not stated | Available |
| 30-K01-6020 | — | Not stated | Available |
| 30-K01-6030 | — | Not stated | Available |
| 30-K01-6040 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Navagio used for?
A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.
Who makes Navagio?
Navagio is made by Kalitec Direct LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Navagio come in?
The FDA device database does not list sizes for Navagio. Check the instructions for use or ask a Kalitec Direct LLC representative.
Is Navagio MRI safe?
The FDA device database entry for Navagio does not state its MRI safety status. Check the labeling before MRI.
Is Navagio FDA cleared?
Navagio is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Kalitec Direct LLC sales representative?
Kalitec Direct LLC has not listed representatives on LA Vascular yet. Visit the Kalitec Direct 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.