Surgical Planning Software version 1.1

Surgical Planning Software version 1.1 is an FDA 510(k)-cleared medical device (K173247) manufactured by Ortho Kinematics, 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 November 7, 2017. Regulation: 8.