Kyphoplasty systems
Bone Filler Kit-HV EU
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 Bone Filler Kit-HV EU
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.
Bone Filler Kit-HV EU 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 |
|---|---|---|---|
| G80007E | — | Not stated | Available |
FDA clearances
- 510(k) K042691 November 2005
Procedures that use kyphoplasty systems
Frequently asked questions
What is Bone Filler Kit-HV EU 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 Bone Filler Kit-HV EU?
Bone Filler Kit-HV EU is made by Izi Medical Products, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Bone Filler Kit-HV EU come in?
The FDA device database does not list sizes for Bone Filler Kit-HV EU. Check the instructions for use or ask a Izi Medical Products, LLC representative.
Is Bone Filler Kit-HV EU MRI safe?
The FDA device database entry for Bone Filler Kit-HV EU does not state its MRI safety status. Check the labeling before MRI.
Is Bone Filler Kit-HV EU FDA cleared?
Bone Filler Kit-HV EU is covered by FDA submission K042691.
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.