Sulzer Medica's BAK/C
This article was originally published in The Gray Sheet
Executive Summary
FDA "approvable" letter for the cervical interbody fusion system is received March 19. The agency's Orthopedic and Rehabilitation Devices Panel unanimously recommended approval of a premarket approval application for the device Jan. 19 (1"The Gray Sheet" Jan. 22, 2001, p. 13). Sulzer estimates the cervical fusion market at approximately $160 mil. this year and annual growth of 19%. Upon final approval by FDA, the BAK/C will be the first cervical interbody fusion device to reach the U.S. market
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