Orthopaedic Devices Panel Recommends Reclassification Of Pedicle Screw Spinal Systems
This article was originally published in The Gray Sheet
FDA’s Orthopaedic and Rehabilitation Devices Panel recommended the downclassification of pedicle screw spinal systems from class III to class II at a May 22 meeting.
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The Orthopaedic and Rehabilitation Advisory Panel recommended FDA require a randomized, sham-control study design with a well-defined patient population to prove safety and effectiveness for the devices. The agency is currently considering whether to retain the preamendments device category in class III or downclassify to class II.
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