Kyphoplasty systems

CosmoLock Pedicle Screw System

by Kalitec Direct LLC

A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

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CosmoLock Pedicle Screw System models and sizes

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

Model / catalog no.SizeMRIStatus
11-K01-5004— Not statedAvailable

Procedures that use kyphoplasty systems

Frequently asked questions

What is CosmoLock Pedicle Screw System used for?

A hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Who makes CosmoLock Pedicle Screw System?

CosmoLock Pedicle Screw System is made by Kalitec Direct LLC. It is listed under vertebral augmentation systems (kyphoplasty and vertebroplasty) in our device library.

What sizes does CosmoLock Pedicle Screw System come in?

The FDA device database does not list sizes for CosmoLock Pedicle Screw System. Check the instructions for use or ask a Kalitec Direct LLC representative.

Is CosmoLock Pedicle Screw System MRI safe?

The FDA device database entry for CosmoLock Pedicle Screw System does not state its MRI safety status. Check the labeling before MRI.

Is CosmoLock Pedicle Screw System FDA cleared?

CosmoLock Pedicle Screw System is registered in the FDA's Global Unique Device Identification Database (GUDID).

How do I contact a Kalitec Direct LLC sales representative?

Kalitec Direct LLC has not listed representatives on LA Vascular yet. Visit the Kalitec Direct 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.

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