Surgical Dynamics, Inc., a Division of United States Surgical Corp.; Premarket Approval of Ray Threaded Fusion Cage (TFC)SUPTM With Instrumentation

摘要

The Food and Drug Administration (FDA) is announcing its approval of the application by Surgical Dynamics, Inc., a division of United States Surgical Corp., Norwalk, CT, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Ray Threaded Fusion Cage (TFC) TM with instrumentation. After reviewing the recommendation of the Orthopedic and Rehabilitation Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of October 29, 1996, of the approval of the application.