CUREXO Gains FDA 510(k) Clearance for CUVIS-spine Surgical Robot

By Julie A. Vetalice

CUREXO Gains FDA 510(k) Clearance for CUVIS-spine Surgical Robot

CUREXO was granted FDA 510(k) clearance to market the CUVIS-spine surgical robot.

The system is available globally, having secured approval under the CE Mark and regulatory clearance in Korea.

CUVIS-spine guides pedicle screw insertion according to the surgical plan, employing a high-precision robot arm and wireless one-step navigation based on a real-time OTS sensor to provide precise, safe and faster surgery vs. manual surgery. CUVIS-spine minimizes the filming and reduces the radiation exposure of both patients and medical staff.

Both 2-dimensional and 3-dimensional filming (C-arm and O-arm, respectively) are applicable with this solution, providing great expandability. Needle, K-wire, dilation and  tapping of traditional manual surgery to be performed with one tool, reducing the length of a procedure.

Mr Jae-Joon Lee, CEO, said, "CUREXO plans to focus on our medical robot sales, including CUVIS-joint, CUVIS-spine and Morning Walk to not only the Korean market but also to advanced medical markets such as the U.S. and Europe."

Product Labels: Robot-Assisted Systems, Spinal Fusion

Tags: 510(k) Clearance, Regulatory