VERTEX Nitinol Staple System

VERTEX Nitinol Staple System is an FDA 510(k)-cleared medical device (K182943) manufactured by Nvision Biomedical Technologies, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2019. Regulation: 8.