The device is renamed “thoracolumbosacral pedicle screw systems” and with the class change went from being regulated under the product code KNB to “special controls.” The FDA also reclassified dynamic stabilization systems, a pedicle screw systems subtype, as class II with the new name of “semi-rigid systems.”
The FDA renamed and clarified the devices to delineate the differences between rigid pedicle screw systems and semi-rigid systems.
The reclassification was effective on Dec. 30, 2016, after a two-year review process.
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