Kyphoplasty systems
INTROX HighV
by Teknimed
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 INTROX HighV
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INTROX HighV 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 |
|---|---|---|---|
| SM-IN3001C | — | MR Safe | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is INTROX HighV 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 INTROX HighV?
INTROX HighV is made by Teknimed. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does INTROX HighV come in?
The FDA device database does not list sizes for INTROX HighV. Check the instructions for use or ask a Teknimed representative.
Is INTROX HighV MRI safe?
The FDA device database lists INTROX HighV as MR Safe. Always follow the specific MRI conditions in the labeling.
Is INTROX HighV FDA cleared?
INTROX HighV is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Teknimed sales representative?
Teknimed has not listed representatives on LA Vascular yet. Visit the Teknimed 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.