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Orthopedic Devices - Reclassification of Pedicle Screw Systems, Henceforth to Be Known as Thoracolumbosacral Pedicle Screw Systems (Us Food and Drug Administration Regulation) (Fda) (2018 Edition) The Law Library

Orthopedic Devices - Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Orthopedic Devices - Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device "thoracolumbosacral pedicle screw systems"; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype "semi-rigid systems"; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type. This book contains: - The complete text of the Orthopedic Devices - Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section