SEVIIN SURFACE REPLACEMENT SHOULDER

SEVIIN SURFACE REPLACEMENT SHOULDER is an FDA 510(k)-cleared medical device (K130635) manufactured by Ingen 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 August 25, 2013. Regulation: 8.