TransLoc 3D

TransLoc 3D is an FDA 510(k)-cleared medical device (K211496) manufactured by Foundation Fusion Solutions, LLC (Dba Cornerloc). 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, 2022. Regulation: 8.