TruLift Expandable Spacer System

TruLift Expandable Spacer System is an FDA 510(k)-cleared medical device (K201721) manufactured by Life Spine, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2020. Regulation: 8.