Arthrex OrthoVis Preoperative Plan

Arthrex OrthoVis Preoperative Plan is an FDA 510(k)-cleared medical device (K151568) manufactured by Custom Orthopaedic Solutions, 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 July 30, 2015. Regulation: 8.