
Arthrex, Inc.
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TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS is an FDA 510(k)-cleared medical device (K043248) manufactured by Arthrex, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 15, 2005. Regulation: 8.