FDAnews
www.fdanews.com/articles/133725-fda-orders-alphatec-to-submit-revised-postmarket-protocol

FDA Orders Alphatec to Submit Revised Postmarket Protocol

January 25, 2011
Time is running out for Alphatec Spine to submit a revised protocol for required postmarket surveillance studies for three of its devices. The FDA ordered the Carlsbad, Calif., company, in October 2009, to conduct the studies for its Zodiac DynaMo and Isobar semi-rigid spinal systems, as well as its Isobar semi-rigid dual dampener, according to the Jan. 11 warning letter posted last week. The agency sent an approvable letter last July, saying it needed more information to complete its review and outlining deficiencies in the protocol. The FDA gave Alphatec 15 days from receipt of the warning letter to submit a revised plan.
Clinical Trials Advisor