Spine-Tech's Comparison Of BAK To Sofamor Inter Fix "Misleading" - FDA
This article was originally published in The Gray Sheet
Executive Summary
Sulzer Spine-Tech's claim that the BAK Interbody Fusion System has been implanted in over 40,000 patients whereas Medtronic Sofamor Danek's Inter Fix device has been used in roughly 200 patients is "misleading" and misrepresents data used to support FDA approval of the devices, FDA says in a Feb. 17 warning letter.