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First Ray Receives FDA 510(k) Clearance for CortiClamp Small Bone Fixation System


First Ray received FDA 510(k) clearance for the CortiClamp™ System for small bone fixation.

CortiClamp is reportedly the first bone screw system to include a second "screw head" that is attached to the distal end of the screw, providing heads on both ends of the shaft to enhance bi-cortical clamping force. To reduce procedural steps, the system includes an all-in-one instrument comprising reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide.

First Ray is a development stage device company incubated and operated by Surgical Frontiers, whose portfolio also includes KATOR

Sources: First Ray, ORTHOWORLD