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First Ray receives FDA clearance for small bone fixation system

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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.

Reference:

www.prnewswire.com/news-releases/first-ray-receives-fda-510k-clearance-for-corticlamp-small-bone-fixation-system-300268525.html