Dallen Medical received 510(k) clearance from the U.S. Food and Drug Administration for its Tensyn Band, intended for acromioclavicular joint and coracoacromial ligament repair in shoulder separation.
The Tensyn Band technology includes proprietary, knotless banding for stabilized fixation of soft tissue in the shoulder, ankle and other anatomy while allowing for physiologically natural movement of the joints. The technology has also been cleared by the FDA for syndesmosis repair.
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