Kyphoplasty systems
Mendec Spine
by Tecres Spa
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 Mendec Spine
We do not have contact details for Tecres Spa yet. Send a request and we will route it to the right person for your country.
Mendec Spine 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 |
|---|---|---|---|
| 1230 | — | Not stated | Available |
FDA clearances
- 510(k) K042415 June 2005
Procedures that use kyphoplasty systems
Frequently asked questions
What is Mendec Spine 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 Mendec Spine?
Mendec Spine is made by Tecres Spa. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.
What sizes does Mendec Spine come in?
The FDA device database does not list sizes for Mendec Spine. Check the instructions for use or ask a Tecres Spa representative.
Is Mendec Spine MRI safe?
The FDA device database entry for Mendec Spine does not state its MRI safety status. Check the labeling before MRI.
Is Mendec Spine FDA cleared?
Mendec Spine is covered by FDA submission K042415.
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.