Entasis 3D Dual-Lead Sacroiliac Implant System

Entasis 3D Dual-Lead Sacroiliac Implant System is an FDA 510(k)-cleared medical device (K223708) 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 March 20, 2023. Regulation: 8.