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First Ray receives FDA clearance for small bone fixation system
First Ray announced it has received FDA 510 (k) clearance for its CortiClamp System for small bone fixation.
Reportedly the first bone screw system with a second “screw head” attached to the distal end of the screw which creates a bi-cortical clamping force, the CortiClamp System offers statistically significantly higher pull-out strength and provides approximately twice the strength in an osteoporotic bone model vs. headless compression screws and cortical screws, according to a press release. The release also notes the CortiClamp System includes an “all-in-one” instrument that serves as a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide which eliminates several surgical procedure steps, streamlines the procedure and reduces operative time.
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