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Woven Orthopedic Technologies, LLC
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OGmend Implant System is an FDA 510(k)-cleared medical device (DEN180065) manufactured by Woven Orthopedic Technologies, 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 April 30, 2020. Regulation: 8.