
Core Essence Orthopaedics
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KNOTLESS SUTURE FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K111716) manufactured by Core Essence Orthopaedics. 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 9, 2011. Regulation: 8.