Healthcare Industry News:  cervical spine 

Devices Orthopaedic Neurosurgery FDA

 News Release - October 31, 2007

Amedica Receives FDA 510(k) Clearance for Valeo(TM) Cervical Plate

SALT LAKE CITY, Oct. 31 (HSMN NewsFeed) -- Amedica Corporation, an orthopedic implants company focused on silicon nitride ceramic technologies, announced today that the U.S. Food and Drug Administration has granted 510(k) marketing clearance to Amedica's Valeo(TM) Cervical Plate system.

The Valeo(TM) Cervical Plate system combines features aimed at making cervical fixation procedures efficient, simple and consistent. The Valeo(TM) Cervical Plate system 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 Ashok Khandkar, Ph.D., Chief Executive Officer of Amedica Corporation. "The clearance of this implant represents another milestone toward the commercialization of our innovative suite of spinal products."

About Amedica

Amedica Corporation is an emerging orthopedic implant company focused on using its silicon nitride ceramic technologies to develop and commercialize a broad range of innovative, high-performance spine and joint implants for the growing orthopedic device market. Its products under development include spine, reconstructive hip and knee implants that may represent a new standard of care in total joint implants based on superior durability, performance and safety.


Source: Amedica

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