ORTHOHUB EXTERNAL FIXATOR SOFTWARE

ORTHOHUB EXTERNAL FIXATOR SOFTWARE is an FDA 510(k)-cleared medical device (K140550) manufactured by Orthohub, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 2014. Regulation: 8.