Kyphoplasty systems

Osteo-site Bone Filler Kit-MV

by Izi Medical Products, LLC

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.

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Osteo-site Bone Filler Kit-MV models and sizes

From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.

Model / catalog no.SizeMRIStatus
G80010— Not statedAvailable
G80011— Not statedAvailable

Procedures that use kyphoplasty systems

Frequently asked questions

What is Osteo-site Bone Filler Kit-MV 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 Osteo-site Bone Filler Kit-MV?

Osteo-site Bone Filler Kit-MV is made by Izi Medical Products, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does Osteo-site Bone Filler Kit-MV come in?

The FDA device database does not list sizes for Osteo-site Bone Filler Kit-MV. Check the instructions for use or ask a Izi Medical Products, LLC representative.

Is Osteo-site Bone Filler Kit-MV MRI safe?

The FDA device database entry for Osteo-site Bone Filler Kit-MV does not state its MRI safety status. Check the labeling before MRI.

Is Osteo-site Bone Filler Kit-MV FDA cleared?

Osteo-site Bone Filler Kit-MV is registered in the FDA's Global Unique Device Identification Database (GUDID).

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.

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