Globus previously considered NuBone to fall under the minimally manipulated tissue exemption from premarket notification, but the FDA determined it required 510(k) clearance in March 2008. The company maintained communication with the FDA but discontinued NuBone in 2010.
The complaint of an alleged violation does not include patient safety issues, and the amended complaint does not allege intentional wrongdoing by the company or Mr. Paul.
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Globus Medical Settles FDA Administrative ComplaintWritten by Laura Miller | March 01, 2012
Globus Medical's Chairman and CEO David Paul announced reaching a settlement with the Food and Drug Administration to result complaints alleging the company violated the Food, Drug and Cosmetic Act with its former product, NuBone.
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