Kyphoplasty systems
B-Two Inflatable bone expander system balloon catheter
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 B-Two Inflatable bone expander system balloon catheter
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B-Two Inflatable bone expander system 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 |
|---|---|---|---|
| US102010 | — | Not stated | Available |
| US102015 | — | Not stated | Available |
| US102020 | — | Not stated | Available |
FDA clearances
- 510(k) K153296 July 2016
Procedures that use kyphoplasty systems
Frequently asked questions
What is B-Two Inflatable bone expander system 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 B-Two Inflatable bone expander system balloon catheter?
B-Two Inflatable bone expander system balloon catheter is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does B-Two Inflatable bone expander system balloon catheter come in?
The FDA device database does not list sizes for B-Two Inflatable bone expander system balloon catheter. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is B-Two Inflatable bone expander system balloon catheter MRI safe?
The FDA device database entry for B-Two Inflatable bone expander system balloon catheter does not state its MRI safety status. Check the labeling before MRI.
Is B-Two Inflatable bone expander system balloon catheter FDA cleared?
B-Two Inflatable bone expander system balloon catheter is covered by FDA submission K153296.
How do I contact a Imedicom Co., Ltd. sales representative?
Imedicom Co., Ltd. has not listed representatives on LA Vascular yet. Visit the Imedicom 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.