EXTRA LARGE QUAD FLEX SPINE COIL

EXTRA LARGE QUAD FLEX SPINE COIL is an FDA 510(k)-cleared medical device (K940602) manufactured by Hitachi Medical Systems America, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 1994. Regulation: 8.