Amedica made a (510)k submission to FDA for its Valeo C+CSC with Lumen spinal implant.
The Valeo C+CSC with Lumen is based on a modified cancellous structured ceramic that is similar to Valeo C+ CSC cervical implants. Valeo with Lumen is intended to increase implant surface area and actively participate in fusion, while retaining other benefits of silicon nitride materials.
The company's Valeo C and Valeo C+ CSC devices are presently cleared for ex-U.S. marketing.
Source: Amedica Corporation