Biomet Microfixation Sternal Closure System

Biomet Microfixation Sternal Closure System is an FDA 510(k)-cleared medical device (K161896) manufactured by Biomet Microfixation. 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 1, 2016. Regulation: 8.