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FDA Approves Gauthier Biomedical's Electronic Torque Indicating Device

The U.S. Food and Drug Administration (FDA) announced that Gauthier Biomedical, Inc. has been granted 510(k) approval for the Intellitorq, an electronic torque indicating device.

Gauthier Biomedical, Inc., a manufacturer of orthopedic instruments and medical devices, announced today that it is the first company to achieve 510(k) approval by the U.S. Food and Drug Administration (FDA) to market an electronic torque indicating device. Intellitorq® (or ITQ® for short) is a manual driver that accurately indicates a preset torque value using LED lights and haptic feedback.

“This breakthrough in handheld medical devices represents Gauthier’s long-standing commitment to providing repeatability, reliability and accuracy to medical device OEMs,” said Michael T. Gauthier, president of Gauthier Biomedical, Inc. “Torque devices and final-tightening needs have long been a source of frustration for quality, regulatory and engineering departments. This new product category of smart instrumentation creates a major market disruption the likes of which we haven’t seen in quite some time. It will improve patient safety, exponentially drive value and eliminate costly recalibration programs.”

With products for hip, knee, shoulder, trauma and spine, Gauthier Biomedical, Inc. provides a wide range of patented technologies designed to improve surgical techniques. Gauthier Biomedical Inc. is located in Grafton, Wisconsin and was founded in 2000. With a team of engineers, over 50 patents and a state-of-the-art 80,000 sq. ft. manufacturing facility, Gauthier Biomedical serves customers from all around the world.

Gauthier Biomedical Inc. is FDA registered and ISO 13485:2003 certified. Limited OEM distributorship opportunities are still available. For information regarding Gauthier's ITQ® go to http://intellitorq.com or email dean.poulos@gauthierbiomedical.com. INTELLITORQ®, ITQ® and the circle G are registered trademarks of Gauthier Biomedical Inc. INTELLITORQ® is covered by European, Japanese and U.S. patents 8,485,075; 8,714,058; 9,358,672; 9,505,109 and other patents pending.

Media Contact:
Dean Poulos
Sales & Marketing Manager
Gauthier Biomedical Inc
2221 Washington St.
Grafton, WI 53024
TF 866-546-0010 x 9004
C 414-840-3290

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