A’TOMIC™ Nitinol Fixation System

A’TOMIC™ Nitinol Fixation System is an FDA 510(k)-cleared medical device (K232990) manufactured by Rmr Ortho, 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 January 11, 2024. Regulation: 8.