Kyphoplasty systems
Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter
by G21 Srl
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 Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter
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Winch Kyphoplasty ( 20 mm) 11 Gauge 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 |
|---|---|---|---|
| 900027 | — | Not stated | Available |
| 900027 | — | Not stated | Available |
| 900028 | — | Not stated | Available |
| 900028 | — | Not stated | Available |
FDA clearances
- 510(k) K172214 August 2017
- 510(k) K152557 February 2016
Procedures that use kyphoplasty systems
Frequently asked questions
What is Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter 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 Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter?
Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter is made by G21 Srl. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter come in?
The FDA device database does not list sizes for Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter. Check the instructions for use or ask a G21 Srl representative.
Is Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter MRI safe?
The FDA device database entry for Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter FDA cleared?
Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter is covered by FDA submissions K152557, K172214.
How do I contact a G21 Srl sales representative?
G21 Srl has not listed representatives on LA Vascular yet. Visit the G21 Srl 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.