Zdrowie i gospodarka · 17/11/1997

Osteonics Corp.; Premarket Approval of the Osteonics Constrained Acetabular Insert

The Food and Drug Administration (FDA) is announcing its approval of the application submitted by Osteonics Corp., Allendale, NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Osteonics Constrained Acetabular Insert. 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 June 13, 1997, of the approval of the application.