OsteoFlo HydroFiber

OsteoFlo HydroFiber is an FDA 510(k)-cleared medical device (K242797) manufactured by SurGenTec, 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 December 22, 2024. Regulation: 8.