Mighty Oak Medical received FDA 510(k) clearance for its 3D-printed, patient-specific Firefly Midline Navigation Guide.
Here are three things to know:
1. The Midline Guide is indicated for use from T10 to S2 and designed for a cortical trajectory.
2. The Midline Guide mechanically constrains the burr to follow the predetermined trajectory, which can eliminate the need for surgery centers to provide an O-arm or robot for these cases.
3. Firefly is compatible with all pedicle screw systems.