Mako Shoulder Application (1.0)

Mako Shoulder Application (1.0) is an FDA 510(k)-cleared medical device (K242373) manufactured by Mako Surgical Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2024. Regulation: 8.