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FDA clears Mighty Oak's 3D-printed navigation guide

Mighty Oak Medical has secured 510(k) clearance for its Firefly midline navigation guide, a 3D-printed and patient-specific device for cortical bone trajectory for pedicle screws during bone fixation. The device can be used with any pedicle screw system and mechanically follows a preset trajectory without the need for an O-arm imaging system or robot.

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