Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is an FDA 510(k)-cleared medical device (K221333) manufactured by Acumed, 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 December 28, 2022. Regulation: 8.