EBI ACUMEN SURGICAL NAVIGATION SYSTEM

EBI ACUMEN SURGICAL NAVIGATION SYSTEM is an FDA 510(k)-cleared medical device (K031732) manufactured by Ebi, L.P.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2003. Regulation: 8.