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Baxano Surgical Receives FDA 510(k) Clearance for Avance MIS Pedicle Screw System

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Baxano Surgical, announced that it has received U.S. Food and Drug Administration 510(k) clearance for its Avance MIS Pedicle Screw System.

The system may be used as an adjunct to fusion in numerous degenerative and complex spinal pathologies. It is intended to help address single, complex and multi-level spinal pathologies with minimal tissue disruption and trauma.

 

A full market launch of the Avance system is planned for the fourth quarter of 2014, with limited market release in the second and third quarter of 2014.

 

Baxano Surgical is a medical device company focused on designing, developing and marketing minimally invasive solutions to treat degenerative conditions of the lumbar spine.  

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