Valkyrie Thoracic Fixation System

Valkyrie Thoracic Fixation System is an FDA 510(k)-cleared medical device (K211695) manufactured by Jm Longyear Manufacturing, LLC D/B/A Able Medical Devices. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 22, 2021. Regulation: 8.