Kyphoplasty systems
BALEX Bone Expander System
A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.
Where to buy BALEX Bone Expander System
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BALEX Bone Expander 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 |
|---|---|---|---|
| BALEX TYP 0510 | — | Not stated | Available |
| BALEX TYP 0515 | — | Not stated | Available |
| BALEX TYP 0520 | — | Not stated | Available |
| BALEX TYP 0520 | — | Not stated | Available |
FDA clearances
- 510(k) K202027 February 2021
Procedures that use kyphoplasty systems
Frequently asked questions
What is BALEX Bone Expander System used for?
A sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.
Who makes BALEX Bone Expander System?
BALEX Bone Expander System is made by Taeyeon Medical co.,Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does BALEX Bone Expander System come in?
The FDA device database does not list sizes for BALEX Bone Expander System. Check the instructions for use or ask a Taeyeon Medical co.,Ltd. representative.
Is BALEX Bone Expander System MRI safe?
The FDA device database entry for BALEX Bone Expander System does not state its MRI safety status. Check the labeling before MRI.
Is BALEX Bone Expander System FDA cleared?
BALEX Bone Expander System is covered by FDA submission K202027.
How do I contact a Taeyeon Medical co.,Ltd. sales representative?
Taeyeon Medical co.,Ltd. has not listed representatives on LA Vascular yet. Visit the Taeyeon Medical co.,Ltd. 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.