EIS THREADED SCREW FRACTURE FIXATION

EIS THREADED SCREW FRACTURE FIXATION is an FDA 510(k)-cleared medical device (K991964) manufactured by Groupe Lepine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 1999. Regulation: 8.