PREMIER 7000 CTL SPINE COIL

PREMIER 7000 CTL SPINE COIL is an FDA 510(k)-cleared medical device (K980157) manufactured by Usa Instruments, 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 April 12, 1998. Regulation: 8.