ToeJack MIS Bunion System

ToeJack MIS Bunion System is an FDA 510(k)-cleared medical device (K253423) manufactured by Nvision Biomedical Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2025. Regulation: 8.