In Brief: Pedicle screw comments
This article was originally published in The Gray Sheet
Executive Summary
Pedicle screw comments: FDA completes its review of comments submitted by Sofamor Danek and Plaintiffs' Legal Committee regarding the agency's proposed downclassification of pedicle bone screws ("The Gray Sheet" June 9, I&W-10). The agency hopes to make a decision on whether to reclassify the devices from Class III to Class II in the next several weeks...