PROSTEP™ TBI™ (Tailors Bunion Implant) System

PROSTEP™ TBI™ (Tailors Bunion Implant) System is an FDA 510(k)-cleared medical device (K190970) manufactured by Wrightmedicaltechnologyinc. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 12, 2019. Regulation: 8.