Amedica Receives FDA 510(k) Clearance For SEEplate(TM) Cervical Plate System

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Medical Devices / Diagnostics
Article Date: 16 Oct 2008 - 0:00 PDT

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Amedica Corporation, an orthopedic and spinal implants company focused on silicon nitride ceramic technologies, announced that the U.S. Food and Drug Administration has granted 510(k) marketing clearance to Amedica's SEEplate(TM) Cervical Plate system.

The SEEplate Cervical Plate system incorporates features that are aimed at allowing surgeons an alternative to confirming the secure placement of the anti-back-out mechanism of screws used as part of the spinal implant system. The SEEplate Cervical Plate system is intended for anterior screw fixation of cervical spine from the C2 through C7 vertebral bodies of the spine as an adjunct to cervical spine 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 SEEplate Cervical Plate system is another important milestone for Amedica," said Ashok Khandkar, Ph.D., Chief Executive Officer of Amedica Corporation. "This cervical plate system will complement our line of innovative, silicon nitride ceramic spinal spacers, providing surgeons and patients with an important new option for spinal fixation."

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.

Amedica Corporation
http://www.amedicacorp.com