Montross Extremity Medical Hemi Implant System

Montross Extremity Medical Hemi Implant System is an FDA 510(k)-cleared medical device (K221220) manufactured by Montross Extremity Medical. 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 18, 2023. Regulation: 8.