REFIX INTERNAL FRACTURE FIXATION SCREWS

REFIX INTERNAL FRACTURE FIXATION SCREWS is an FDA 510(k)-cleared medical device (K050388) manufactured by Xtremi-T, 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 September 6, 2005. Regulation: 8.