EIDOSMED, MODEL EDG4.0

EIDOSMED, MODEL EDG4.0 is an FDA 510(k)-cleared medical device (K091992) manufactured by Eidosmed, 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 December 8, 2009. Regulation: 8.