Kyphoplasty systems
Kyphoplasty Balloon Catheter
by Jiangsu Changmei Medtech Co., Ltd.
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 Kyphoplasty Balloon Catheter
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Kyphoplasty Balloon Catheter 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 |
|---|---|---|---|
| KB0115S1 | — | Not stated | Available |
| KB0120S1 | — | Not stated | Available |
| KB0210S1 | — | Not stated | Available |
FDA clearances
- 510(k) K223709 August 2023
Procedures that use kyphoplasty systems
Frequently asked questions
What is Kyphoplasty Balloon Catheter 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 Kyphoplasty Balloon Catheter?
Kyphoplasty Balloon Catheter is made by Jiangsu Changmei Medtech Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Kyphoplasty Balloon Catheter come in?
The FDA device database does not list sizes for Kyphoplasty Balloon Catheter. Check the instructions for use or ask a Jiangsu Changmei Medtech Co., Ltd. representative.
Is Kyphoplasty Balloon Catheter MRI safe?
The FDA device database entry for Kyphoplasty Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Kyphoplasty Balloon Catheter FDA cleared?
Kyphoplasty Balloon Catheter is covered by FDA submission K223709.
How do I contact a Jiangsu Changmei Medtech Co., Ltd. sales representative?
Jiangsu Changmei Medtech Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Jiangsu Changmei Medtech 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.