EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM

EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K970290) 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 March 31, 1997. Regulation: 8.