Kyphoplasty systems
Spinoplasty Kit
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 Spinoplasty Kit
We do not have contact details for Izi Medical Products, LLC yet. Send a request and we will route it to the right person for your country.
Spinoplasty 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 |
|---|---|---|---|
| G80006 | — | Not stated | Available |
FDA clearances
- 510(k) K103433 January 2011
- 510(k) K022074 August 2002
Procedures that use kyphoplasty systems
Frequently asked questions
What is Spinoplasty 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 Spinoplasty Kit?
Spinoplasty Kit is made by Izi Medical Products, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Spinoplasty Kit come in?
The FDA device database does not list sizes for Spinoplasty Kit. Check the instructions for use or ask a Izi Medical Products, LLC representative.
Is Spinoplasty Kit MRI safe?
The FDA device database entry for Spinoplasty Kit does not state its MRI safety status. Check the labeling before MRI.
Is Spinoplasty Kit FDA cleared?
Spinoplasty Kit is covered by FDA submissions K022074, K103433.
How do I contact a Izi Medical Products, LLC sales representative?
Izi Medical Products, LLC has not listed representatives on LA Vascular yet. Visit the Izi Medical Products, 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.