Amedica Submits FDA 510(k) for Valeo Implant with Lumen

By Julie A. Vetalice

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

Product Labels: Spinal Fusion

Tags: Regulatory