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Semi-Rigid Spine Systems Will Escape PMAs, But Not Clinical Mandate

Executive Summary

US FDA has completed a long-running effort to reclassify pedicle screw systems, which are widely used devices for spine fusion procedures. The final policy: all pedicle screws intended as an adjunct to fusion surgery are class II/special controls devices, but "semi-rigid" systems will require clinical data to support 510(k) clearance while more traditional, rigid systems will not.


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