![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Mighty Oak Medical’s Midline Navigation Guide Cleared
Mighty Oak Medical’s Midline Navigation Guide Cleared
![ClearanceStamp_Orange.gif](https://www.fdanews.com/ext/resources/test/Device_Images6/ClearanceStamp_Orange.gif?t=1609798625&width=430)
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.
Upcoming Events
-
21Oct