FDA orders postmarket studies of spinal devices

The FDA has asked orthopedic device firms to conduct postmarket studies of dynamic stabilization systems, a type of pedicle screw device designed to support the spinal column during bone fusion procedures, to determine the fusion rate and other potential safety issues. Representatives from at least two device firms, DePuy and Medtronic, have said they will comply with the agency's request.

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Times-Union (Warsaw, Ind.) · Clinica (subscription required)

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