Biopsy needles
Kyphoplasty Coaxial Cement Injector
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Kyphoplasty Coaxial Cement Injector 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 |
|---|---|---|---|
| VA11CC | — | Not stated | Available |
FDA clearances
- 510(k) K170008 February 2017
Procedures that use biopsy needles
Frequently asked questions
What is Kyphoplasty Coaxial Cement Injector used for?
A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Who makes Kyphoplasty Coaxial Cement Injector?
Kyphoplasty Coaxial Cement Injector is made by Izi Medical Products, LLC. It is listed under biopsy needles and systems in our device library.
What sizes does Kyphoplasty Coaxial Cement Injector come in?
The FDA device database does not list sizes for Kyphoplasty Coaxial Cement Injector. Check the instructions for use or ask a Izi Medical Products, LLC representative.
Is Kyphoplasty Coaxial Cement Injector MRI safe?
The FDA device database entry for Kyphoplasty Coaxial Cement Injector does not state its MRI safety status. Check the labeling before MRI.
Is Kyphoplasty Coaxial Cement Injector FDA cleared?
Kyphoplasty Coaxial Cement Injector is covered by FDA submission K170008.
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.