Mighty Oak Medical’s Midline Navigation Guide Cleared

The FDA granted Mighty Oak Medical 510(k) clearance for its Firefly midline navigation guide, a 3D-printed and patient-specific device designed for cortical bone trajectory for pedicle screws.

The Firefly, which is used for bone fixation, is compatible with every pedicle screw system.

The guide mechanically follows a predetermined trajectory and can eliminate the need for an O-arm imaging system or robot.