Zdrowie i gospodarka · 30/12/2016

FDA Reclassifies Pedicle Screw Systems as Thoracolumbosacral Pedicle Screw Systems and Semi-Rigid Systems

The FDA is reclassifying pedicle screw systems, a type of orthopedic device, from a Class III to a Class II device, renaming them as thoracolumbosacral pedicle screw systems and semi-rigid systems, in an effort to improve device identification and clarity.