Kyphoplasty systems
Mvx US
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
Where to buy Mvx US
We do not have contact details for Imedicom Co., Ltd. yet. Send a request and we will route it to the right person for your country.
Mvx US 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 |
|---|---|---|---|
| MVX-01 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Mvx US used for?
A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
Who makes Mvx US?
Mvx US is made by Imedicom Co., Ltd.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Mvx US come in?
The FDA device database does not list sizes for Mvx US. Check the instructions for use or ask a Imedicom Co., Ltd. representative.
Is Mvx US MRI safe?
The FDA device database entry for Mvx US does not state its MRI safety status. Check the labeling before MRI.
Is Mvx US FDA cleared?
Mvx US is registered in the FDA's Global Unique Device Identification Database (GUDID).
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.