Medusa Orthopedics Boa External Fixation System

Medusa Orthopedics Boa External Fixation System is an FDA 510(k)-cleared medical device (K252555) manufactured by Medusa Orthopedics, LLC. 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 24, 2025. Regulation: 8.