Kyphoplasty systems
Cement Kit
by Tecres Spa
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Cement 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 |
|---|---|---|---|
| KITCEMENT-US | — | Not stated | Available |
FDA clearances
- 510(k) K122175 March 2013
Procedures that use kyphoplasty systems
Frequently asked questions
What is Cement Kit used for?
A collection of sterile surgical instruments, tools, and materials designed to prepare and apply bone cement during an orthopaedic surgical procedure (e.g., hip replacement, arthroplasty, or vertebroplasty). It typically includes items such as forceps, a mallet, cement delivery injectors, delivery tubes, and mixing devices; it may or may not include bone cement. This is a single-use device.
Who makes Cement Kit?
Cement Kit is made by Tecres Spa. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Cement Kit come in?
The FDA device database does not list sizes for Cement Kit. Check the instructions for use or ask a Tecres Spa representative.
Is Cement Kit MRI safe?
The FDA device database entry for Cement Kit does not state its MRI safety status. Check the labeling before MRI.
Is Cement Kit FDA cleared?
Cement Kit is covered by FDA submission K122175.
How do I contact a Tecres Spa sales representative?
Tecres Spa has not listed representatives on LA Vascular yet. Visit the Tecres Spa 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.