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Core Essence Orthopaedics, LLC
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FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 is an FDA 510(k)-cleared medical device (K081060) manufactured by Core Essence Orthopaedics, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 23, 2008. Regulation: 8.