In2Bones Fracture and Correction System

In2Bones Fracture and Correction System is an FDA 510(k)-cleared medical device (K170518) 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 13, 2017. Regulation: 8.