EBI XFIX DFS RAIL SYSTEM

EBI XFIX DFS RAIL SYSTEM is an FDA 510(k)-cleared medical device (K991941) manufactured by Electro-Biology, 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 August 18, 1999. Regulation: 8.