Kyphoplasty systems
Winch Kyphoplasty Bilateral Kit 20 mm
by G21 Srl
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 Winch Kyphoplasty Bilateral Kit 20 mm
We do not have contact details for G21 Srl yet. Send a request and we will route it to the right person for your country.
Winch Kyphoplasty Bilateral Kit 20 mm 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 |
|---|---|---|---|
| 900016B | — | Not stated | Available |
| 900018B | — | Not stated | Available |
| 900207B | — | Not stated | Available |
| 900208B | — | Not stated | Available |
FDA clearances
- 510(k) K172214 August 2017
Procedures that use kyphoplasty systems
Frequently asked questions
What is Winch Kyphoplasty Bilateral Kit 20 mm 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 Winch Kyphoplasty Bilateral Kit 20 mm?
Winch Kyphoplasty Bilateral Kit 20 mm is made by G21 Srl. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Winch Kyphoplasty Bilateral Kit 20 mm come in?
The FDA device database does not list sizes for Winch Kyphoplasty Bilateral Kit 20 mm. Check the instructions for use or ask a G21 Srl representative.
Is Winch Kyphoplasty Bilateral Kit 20 mm MRI safe?
The FDA device database entry for Winch Kyphoplasty Bilateral Kit 20 mm does not state its MRI safety status. Check the labeling before MRI.
Is Winch Kyphoplasty Bilateral Kit 20 mm FDA cleared?
Winch Kyphoplasty Bilateral Kit 20 mm is covered by FDA submission K172214.
How do I contact a G21 Srl sales representative?
G21 Srl has not listed representatives on LA Vascular yet. Visit the G21 Srl 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.