The Entasis Dual-Lead Sacroiliac Implant

The Entasis Dual-Lead Sacroiliac Implant is an FDA 510(k)-cleared medical device (K152237) manufactured by Corelink, 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 February 3, 2016. Regulation: 8.