Kyphoplasty systems
V-Fast
by G21 Srl
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Where to buy V-Fast
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.
V-Fast 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 |
|---|---|---|---|
| 800036 | — | Not stated | Available |
FDA clearances
- 510(k) K150408 December 2015
Procedures that use kyphoplasty systems
Frequently asked questions
What is V-Fast used for?
A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.
Who makes V-Fast?
V-Fast is made by G21 Srl. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does V-Fast come in?
The FDA device database does not list sizes for V-Fast. Check the instructions for use or ask a G21 Srl representative.
Is V-Fast MRI safe?
The FDA device database entry for V-Fast does not state its MRI safety status. Check the labeling before MRI.
Is V-Fast FDA cleared?
V-Fast is covered by FDA submission K150408.
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.