
Arthrex, Inc.
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TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 is an FDA 510(k)-cleared medical device (K011007) 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 June 11, 2001. Regulation: 8.