In Brief: Sofamor Danek
This article was originally published in The Gray Sheet
Executive Summary
Sofamor Danek: Premarket approval application for firm's Novus LC threaded interbody spinal fusion system is anticipated to undergo review by FDA's Orthopedic and Rehabilitation Devices Panel in November, Chairman and CEO Ron Pickard said at a Sept. 4 session of the Jeffries and Company medical device conference in New York City. The PMA application was submitted March 24 and is undergoing interactive review at FDA. S-D competitors U.S. Surgical and Spine-Tech are opposing FDA approval of the PMA...