IBS-B MIS Beveled Screw System

IBS-B MIS Beveled Screw System is an FDA 510(k)-cleared medical device (K231236) manufactured by In2bones USA, 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 July 26, 2023. Regulation: 8.