Globus Medical has received FDA 510(k) clearance for its ExcelsiusFlex orthopedics robot, according to a June 17 website posting from the agency.
In a May investor call, Globus said it had filed for approval of the robot. The ExcelsiusFlex is designed to provide stereotaxic guidance during orthopedic joint or spine surgeries.
Globus hopes to gain a share of the $15 billion global reconstruction market with the new robot, according to market analysts.