Kyphoplasty systems
KIT: VCF Treatment, LEFT, FRACTURE
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 KIT: VCF Treatment, LEFT, FRACTURE
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.
KIT: VCF Treatment, LEFT, FRACTURE 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 |
|---|---|---|---|
| KIVA2200E | — | MR Conditional | Available |
FDA clearances
- 510(k) K141141 August 2014
Procedures that use kyphoplasty systems
Frequently asked questions
What is KIT: VCF Treatment, LEFT, FRACTURE 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 KIT: VCF Treatment, LEFT, FRACTURE?
KIT: VCF Treatment, LEFT, FRACTURE is made by Izi Medical Products, LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does KIT: VCF Treatment, LEFT, FRACTURE come in?
The FDA device database does not list sizes for KIT: VCF Treatment, LEFT, FRACTURE. Check the instructions for use or ask a Izi Medical Products, LLC representative.
Is KIT: VCF Treatment, LEFT, FRACTURE MRI safe?
The FDA device database lists KIT: VCF Treatment, LEFT, FRACTURE as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is KIT: VCF Treatment, LEFT, FRACTURE FDA cleared?
KIT: VCF Treatment, LEFT, FRACTURE is covered by FDA submission K141141.
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.