Sulzer Cervical Fusion System Gains Panel Nod; Firm May Be First To Market
This article was originally published in The Gray Sheet
Sulzer Spine-Tech should perform a sensitivity analysis on existing data to make a stronger case that patients who dropped out of the study's control group did not bias conclusions in favor of the firm's BAK/C cervical interbody fusion system, FDA's Orthopedic and Rehabilitation Devices panel recommended.
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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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