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Trilliant Surgical, Ltd.
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3S HEMI TOE is an FDA 510(k)-cleared medical device (K072922) manufactured by Trilliant Surgical, Ltd.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 27, 2007. Regulation: 8.