SALT LAKE CITY, Nov. 26 /PRNewswire/ -- 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) Pedicle Screw system.
The Valeo Pedicle Screw system is a low profile and modular pedicle screw system incorporating features that are aimed at allowing surgeons greater flexibility in the positioning of these spinal implants. The Valeo Pedicle Screw system is intended for non-cervical pedicle fixation from the T1 through L5 vertebral bodies of the spine as an adjunct to fusion. The implant and related instruments are designed to facilitate greater modularity and to better suit patient anatomy and achieve a consistent supplemental fixation outcome for many indications including degenerative disc disease, spinal stenosis and failed prior spine fusion surgery.
"FDA clearance of our Valeo Pedicle Screw System is another important milestone for Amedica," said Ashok Khandkar, Ph.D., Chief Executive Officer of Amedica Corporation. "Our pedicle screw system and recently cleared cervical plate will complement our line of innovative, silicon nitride ceramic spinal spacers, providing surgeons and patients with an important new option for spinal fixation."
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.
Ashok C. Khandkar
Chief Executive Officer
|SOURCE Amedica Corporation|
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