MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM

MODIFICATION TO ENDOSCOPIC SPINAL ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K994425) manufactured by Endius, 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 February 15, 2000. Regulation: 8.