CTL-63 AND CTL-128 SPINE ARRAY COILS

CTL-63 AND CTL-128 SPINE ARRAY COILS is an FDA 510(k)-cleared medical device (K062767) manufactured by Invivo Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 2006. Regulation: 8.