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[November 2007]
FDA Gives Market Clearance To Amedica Plate System
Amedica Corporation (Salt Lake City, Utah, USA), an orthopaedic implants company focused on silicon nitride ceramic technologies, has announced that the US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Amedica's Valeo™ Cervical Plate system.
The Valeo™ Cervical Plate system combines features aimed at making cervical fixation procedures efficient, simple and consistent. It is intended for anterior screw fixation at the C2 through C7 vertebral bodies of the cervical spine. The implant and related instruments are designed to facilitate placement of the cervical plate and ensure proper angling and insertion of the screws into the vertebrae in a single step, to achieve a consistent supplemental fixation outcome.
"We are extremely pleased to receive FDA clearance of the Valeo CP system," said Dr Ashok Khandkar, CEO of Amedica Corporation. "The clearance of this implant represents another milestone toward the commercialization of our innovative suite of spinal products."
ENDS