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Pedicle screw Class II indication expansion suggested by Smith & Nephew Richards.

This article was originally published in The Gray Sheet

Executive Summary

PEDICLE SCREW CLASS II INDICATION EXPANSION SOUGHT BY SMITH & NEPHEW Richards in written comments on FDA's Oct. 4 proposed rule on classification of the device. The company says "there is adequate scientific support" for the addition of spinal stenosis, foraminal stenosis and degenerative disc disease in the list of indications for Class II pedicle screws.



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