
Matrix Surgical Holdings, LLC/Matrix Surgical USA
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OmniPore DUROMAX Surgical Implants is an FDA 510(k)-cleared medical device (K180249) manufactured by Matrix Surgical Holdings, LLC/Matrix Surgical USA. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 10, 2018. Regulation: 8.