REPROCESSED EXTERNAL FIXATION DEVICE

REPROCESSED EXTERNAL FIXATION DEVICE is an FDA 510(k)-cleared medical device (K061759) manufactured by Ascent Healthcare Solutions. 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 4, 2006. Regulation: 8.