Kyphoplasty systems
Osseoflex SB Steerable Balloon (8ga/)
by Osseon LLC
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 Osseoflex SB Steerable Balloon (8ga/)
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Osseoflex SB Steerable Balloon (8ga/) 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 |
|---|---|---|---|
| OF-0005 | Needle Gauge 9 G; Total Volume 4 mL | Not stated | Available |
| OF-0222 | Needle Gauge 11 G; Total Volume 2 mL | Not stated | Available |
| OF-0224 | Needle Gauge 11 G; Total Volume 4 mL | Not stated | Available |
| OF-8222 | Needle Gauge 9 G; Total Volume 2 mL | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is Osseoflex SB Steerable Balloon (8ga/) 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 Osseoflex SB Steerable Balloon (8ga/)?
Osseoflex SB Steerable Balloon (8ga/) is made by Osseon LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Osseoflex SB Steerable Balloon (8ga/) come in?
Sizes listed for Osseoflex SB Steerable Balloon (8ga/): Needle Gauge: 9–11 G; Total Volume: 2–4 mL. Confirm availability with the manufacturer's instructions for use.
Is Osseoflex SB Steerable Balloon (8ga/) MRI safe?
The FDA device database entry for Osseoflex SB Steerable Balloon (8ga/) does not state its MRI safety status. Check the labeling before MRI.
Is Osseoflex SB Steerable Balloon (8ga/) FDA cleared?
Osseoflex SB Steerable Balloon (8ga/) is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Osseon LLC sales representative?
Osseon LLC has not listed representatives on LA Vascular yet. Visit the Osseon LLC 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.