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Medical Devices / Submissions and Approvals

Tenon Medical’s Joint Fusion System Cleared by FDA

July 6, 2018

The FDA granted 510(k) clearance for Tenon Medical’s Catamaran sacroiliac joint fixation system.

The system is indicated for performing sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, common causes of pain in the legs, lower back and the sacroiliac joint.

The device allows surgeons to choose between using a navigated procedure or fluoroscopic imaging while the implant is designed to allow for bone graft materials to be loaded and delivered before and after placement.

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