HA Minuteman G3-R MIS Fusion Plate

HA Minuteman G3-R MIS Fusion Plate is an FDA 510(k)-cleared medical device (K163428) manufactured by Spinal Simplicity. 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 1, 2017. Regulation: 8.