Kyphoplasty systems

Confidence Spinal Cement System

by Medos International Sàrl

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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Confidence Spinal Cement System models and sizes

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

Model / catalog no.SizeMRIStatus
283905000— Not statedAvailable
283910000— Not statedAvailable
283913000— Not statedAvailable

FDA clearances

  • 510(k) K060300 June 2006

Procedures that use kyphoplasty systems

Frequently asked questions

What is Confidence Spinal Cement System 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 Confidence Spinal Cement System?

Confidence Spinal Cement System is made by Medos International Sàrl. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does Confidence Spinal Cement System come in?

The FDA device database does not list sizes for Confidence Spinal Cement System. Check the instructions for use or ask a Medos International Sàrl representative.

Is Confidence Spinal Cement System MRI safe?

The FDA device database entry for Confidence Spinal Cement System does not state its MRI safety status. Check the labeling before MRI.

Is Confidence Spinal Cement System FDA cleared?

Confidence Spinal Cement System is covered by FDA submission K060300.

How do I contact a Medos International Sàrl sales representative?

Medos International Sàrl has not listed representatives on LA Vascular yet. Visit the Medos International Sàrl 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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