Response Ortho Metaphyseal Hinge Fixator System

Response Ortho Metaphyseal Hinge Fixator System is an FDA 510(k)-cleared medical device (K241769) manufactured by Response Ortho Solutions, 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 September 17, 2024. Regulation: 8.