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Parcus Medical, LLC
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PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 is an FDA 510(k)-cleared medical device (K083619) manufactured by Parcus 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 March 5, 2009. Regulation: 8.