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Aptis Medical, LLC
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DISTAL RADIO-ULNAR JOINT IMPLANT is an FDA 510(k)-cleared medical device (K082839) manufactured by Aptis Medical, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2008. Regulation: 8.