BioBrace® Extra-Articular Ligament Augmentation Kit

BioBrace® Extra-Articular Ligament Augmentation Kit is an FDA 510(k)-cleared medical device (K252946) manufactured by Conmed Corporation. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2025. Regulation: 8.