Amedica has filed a submission for 510(k) clearance of the Valeo C Interbody with CsC Osteo-Conductive Scaffolding (Valeo CCsC) with the US Food and Drug Administration (FDA) relating to its composite silicon nitride spinal interbody devices.
“Following the impressive cervical fusion outcomes from our CASCADE clinical trial, I am proud to announce that a 510(k) application for our Valeo CCsC silicon nitride devices has been submitted to the FDA, and has passed their administrative review,” said Sonny Bal, chairman and chief executive officer of Amedica. “The product is already cleared for sale in Europe. With the FDA application, we now seek to achieve clearance in the US for our novel, porous synthetic interbody device that has shown fusion rates equivalent to a patient’s own bone.”
Pursuant to Section 510(k), the FDA has 90 days in which to clear the class II medical device for commercial distribution or to seek additional information. The FDA previously confirmed that it would review the product as a medical device. Following notification of FDA clearance, the company would immediately have the right to commence manufacturing, marketing and sales of the product in the USA and its possessions subject to FDA jurisdiction.