CONCEPT ENDOSTEAL FIXATION DEVICE

CONCEPT ENDOSTEAL FIXATION DEVICE is an FDA 510(k)-cleared medical device (K912640) manufactured by Concept, 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 April 30, 1992. Regulation: 8.