Kyphoplasty systems
StabiliT First Fracture Kit
by Dfine, Inc.
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 StabiliT First Fracture Kit
We do not have contact details for Dfine, Inc. yet. Send a request and we will route it to the right person for your country.
StabiliT First Fracture Kit 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 |
|---|---|---|---|
| 2003 | — | Not stated | Available |
| 2003-1 | — | Not stated | Available |
| 3353 | — | Not stated | Available |
| 3353-01 | — | Not stated | Available |
Procedures that use kyphoplasty systems
Frequently asked questions
What is StabiliT First Fracture Kit 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 StabiliT First Fracture Kit?
StabiliT First Fracture Kit is made by Dfine, Inc.. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does StabiliT First Fracture Kit come in?
The FDA device database does not list sizes for StabiliT First Fracture Kit. Check the instructions for use or ask a Dfine, Inc. representative.
Is StabiliT First Fracture Kit MRI safe?
The FDA device database entry for StabiliT First Fracture Kit does not state its MRI safety status. Check the labeling before MRI.
Is StabiliT First Fracture Kit FDA cleared?
StabiliT First Fracture Kit is registered in the FDA's Global Unique Device Identification Database (GUDID).
How do I contact a Dfine, Inc. sales representative?
Dfine, Inc. has not listed representatives on LA Vascular yet. Visit the Dfine, Inc. 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.