Fed Regist. 2016 Dec 30;81(251):96366-74.
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.
美国食品药品监督管理局（FDA）正在发布一项最终命令，将椎弓根螺钉系统（一种修正案前的III类设备，产品代码为NKB）重新分类为II类（特殊控制），并将该设备重新命名为“胸腰骶椎弓根螺钉系统”；将动态稳定系统（当用作融合辅助设备时，根据产品代码NQP进行监管的椎弓根螺钉系统的一个子类型）重新分类为II类（特殊控制），并将该设备子类型重新命名为“半刚性系统”；同时明确椎弓根螺钉系统的设备标识，以便更清晰地区分刚性椎弓根螺钉系统和半刚性系统。FDA基于对与该设备类型相关信息的重新评估，最终确定了这一行动。
