HyperFlex™ Bunion Correction System

HyperFlex™ Bunion Correction System is an FDA 510(k)-cleared medical device (K241995) manufactured by Footbridge 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 November 25, 2024. Regulation: 8.