Kyphoplasty systems

Mendec Spine 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.

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Where to buy Mendec Spine Kit

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Mendec Spine Kit models and sizes

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

Model / catalog no.SizeMRIStatus
13C2000— Not statedAvailable

FDA clearances

  • 510(k) K062452 September 2006

Procedures that use kyphoplasty systems

Frequently asked questions

What is Mendec Spine 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 Mendec Spine Kit?

Mendec Spine Kit is made by Tecres Spa. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does Mendec Spine Kit come in?

The FDA device database does not list sizes for Mendec Spine Kit. Check the instructions for use or ask a Tecres Spa representative.

Is Mendec Spine Kit MRI safe?

The FDA device database entry for Mendec Spine Kit does not state its MRI safety status. Check the labeling before MRI.

Is Mendec Spine Kit FDA cleared?

Mendec Spine Kit is covered by FDA submission K062452.

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.

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