Ignite Stemless Anatomic Shoulder System

Ignite Stemless Anatomic Shoulder System is an FDA 510(k)-cleared medical device (K203108) manufactured by Ignite 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 July 15, 2021. Regulation: 8.