Kyphoplasty systems
ZAVATION ZVplasty Balloon Catheter
by Zavation LLC
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp 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, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Where to buy ZAVATION ZVplasty Balloon Catheter
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ZAVATION ZVplasty 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 |
|---|---|---|---|
| VCF-1015-FLEX-1 | — | Not stated | Available |
| VCF-1020-FLEX-1 | — | Not stated | Available |
FDA clearances
- 510(k) K141419 September 2014
Procedures that use kyphoplasty systems
Frequently asked questions
What is ZAVATION ZVplasty Balloon Catheter used for?
A collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp 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, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.
Who makes ZAVATION ZVplasty Balloon Catheter?
ZAVATION ZVplasty Balloon Catheter is made by Zavation LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does ZAVATION ZVplasty Balloon Catheter come in?
The FDA device database does not list sizes for ZAVATION ZVplasty Balloon Catheter. Check the instructions for use or ask a Zavation LLC representative.
Is ZAVATION ZVplasty Balloon Catheter MRI safe?
The FDA device database entry for ZAVATION ZVplasty Balloon Catheter does not state its MRI safety status. Check the labeling before MRI.
Is ZAVATION ZVplasty Balloon Catheter FDA cleared?
ZAVATION ZVplasty Balloon Catheter is covered by FDA submission K141419.
How do I contact a Zavation LLC sales representative?
Zavation LLC has not listed representatives on LA Vascular yet. Visit the Zavation 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.