EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS

EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS is an FDA 510(k)-cleared medical device (K992367) 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 September 22, 1999. Regulation: 8.