Kyphoplasty systems
SpineKure Kyphoplasty System
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Where to buy SpineKure Kyphoplasty System
We do not have contact details for Han Chang Co., Ltd yet. Send a request and we will route it to the right person for your country.
SpineKure Kyphoplasty 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 |
|---|---|---|---|
| Balloon Catheter (SBC-10) | — | Not stated | Available |
| Balloon Catheter (SBC-15) | — | Not stated | Available |
| Balloon Catheter (SBC-20) | — | Not stated | Available |
| Balloon Inflator (SBI) | — | Not stated | Available |
| Cement Delivery System (SCDS) | — | Not stated | Available |
| SpineKure Kyphoplasty System | — | Not stated | Available |
FDA clearances
- 510(k) K172871 May 2018
Procedures that use kyphoplasty systems
Frequently asked questions
What is SpineKure Kyphoplasty System used for?
A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device.
Who makes SpineKure Kyphoplasty System?
SpineKure Kyphoplasty System is made by Han Chang Co., Ltd. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does SpineKure Kyphoplasty System come in?
The FDA device database does not list sizes for SpineKure Kyphoplasty System. Check the instructions for use or ask a Han Chang Co., Ltd representative.
Is SpineKure Kyphoplasty System MRI safe?
The FDA device database entry for SpineKure Kyphoplasty System does not state its MRI safety status. Check the labeling before MRI.
Is SpineKure Kyphoplasty System FDA cleared?
SpineKure Kyphoplasty System is covered by FDA submission K172871.
How do I contact a Han Chang Co., Ltd sales representative?
Han Chang Co., Ltd has not listed representatives on LA Vascular yet. Visit the Han Chang 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.