Sulzer OrthopedicsRegister, Inc.; Premarket Approval of the Natural Knee and Natural KneeRegister II with Cancellous Structured Titanium (CSTiSUPTM/SUP)

Streszczenie

The Food and Drug Administration (FDA) is announcing its approval of the application submitted by Sulzer Orthopedics , Inc., Austin, TX, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Natural Knee and Natural Knee II with Cancellous Structured Titanium (CSTi TM ). 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 March 21, 1997, of the approval of the application.