Neo Medical lands FDA approval and CE certification for Pedicle Screw System

Neo Medical

Neo Medical has received US Food and Drug Administration (FDA) 510(k) clearance for the use of its Pedicle Screw System in late stage tumour indications, in combination with BonOs Inject cement from OSARTIS. The company also obtained CE certification for its 8mm screws, iliac screws and connectors, as well as rod-to-rod connectors.

Commenting on two regulatory milestones for the European and the US market, Vincent Lefauconnier, Neo Medical CEO, said: “The FDA 510(k) clearance and CE certification announced today (June 16) come as we continue to expand our portfolio and develop new applications for NEO Pedicle Screw System.

“The rest of the year should see the company continuing to expand its activities, including in the digital space with the roll-out of groundbreaking augmented reality solutions to complement our existing platform of physical products.”


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