EBI XFIX DFS OPTIROM ELBOW FIXATOR

EBI XFIX DFS OPTIROM ELBOW FIXATOR is an FDA 510(k)-cleared medical device (K992515) manufactured by Ebi, L.P.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1999. Regulation: 8.