Globus Medical to File Revised 510(k) for ExcelsiusGPS

Globus Medical (GMED) received a letter from FDA, indicating that the company had not sufficiently addressed questions on its 510(k) submission for the ExcelsiusGPS™ robotic guidance and navigation system. GMED will expedite a revised filing, and no longer expects to receive FDA clearance in 2Q17.

Globus reiterated its full-year 2017 revenue...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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