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

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Additional Relevant Details The CortiClamp System, a two-part bone screw system for small bone fixation, represents a significant advancement in fracture fixation, osteotomy and arthrodesis procedures that are currently treated using conventional bone screws, such as cortical screws, lag screws and headless compression screws. The CortiClamp System is the first bone screw system to include a second "screw head" that is attached to the distal end of the screw, providing screw heads on both ends of the screw shaft that create superior  bi-cortical clamping force. The CortiClamp System also includes an innovative "all-in-one" instrument that serves as a reduction clamp, drill guide, countersink guide, depth gage and implant delivery guide. This instrument eliminates several surgical procedure steps, including placement of provisional fixation, which streamlines the procedure and reduces operative time.
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Catalyst Date
Occurred on:
May 16, 2016
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Related Keywords 501k Clearance, Corticlamp, Small Bone Fixation System