Comprehensive SRS/Nexel Elbow

Comprehensive SRS/Nexel Elbow is an FDA 510(k)-cleared medical device (K153398) manufactured by Biomet Manufacturing Corp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 2, 2016. Regulation: 8.