SOFAMOR DANEK NOVUS LC THREADED SPINAL FUSION CAGE NOT APPROVABLE DUE TO LACK OF TWO-YEAR FOLLOW-UP DATA, FDA ORTHOPEDIC PANEL SAYS IN 6-2 VOTE
This article was originally published in The Gray Sheet
Executive Summary
Sofamor Danek's premarket approval application for the Novus LC threaded spinal fusion cage is not approvable primarily due to its lack of two-year follow-up data, FDA's Orthopedic and Rehabilitation Devices Advisory Panel concluded at a Dec. 11 meeting in Bethesda, Maryland.