ORTHOVIS PREOPERATIVE PLAN

ORTHOVIS PREOPERATIVE PLAN is an FDA 510(k)-cleared medical device (K133367) manufactured by Custom Orthopaedic Solutions. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 19, 2013. Regulation: 8.