SALT LAKE CITY, Oct. 31 Amedica Corporation, anorthopedic 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 makingcervical fixation procedures efficient, simple and consistent. The Valeo(TM)Cervical Plate system is intended for anterior screw fixation at the C2through C7 vertebral bodies of the cervical spine. The implant and relatedinstruments are designed to facilitate placement of the cervical plate andensure proper angling and insertion of the screws into the vertebrae in asingle step, to achieve a consistent supplemental fixation outcome.
"We are extremely pleased to receive FDA clearance of the Valeo CPsystem," said Ashok Khandkar, Ph.D., Chief Executive Officer of AmedicaCorporation. "The clearance of this implant represents another milestonetoward the commercialization of our innovative suite of spinal products."
Amedica Corporation is an emerging orthopedic implant company focused onusing its silicon nitride ceramic technologies to develop and commercialize abroad range of innovative, high-performance spine and joint implants for thegrowing orthopedic device market. Its products under development includespine, reconstructive hip and knee implants that may represent a new standardof care in total joint implants based on superior durability, performance andsafety.Contact: Ashok C. Khandkar Chief Executive Officer (801) 583-5100 Email: [email protected]
SOURCE Amedica Corporation