The TiBow Expandable Spacer System

The TiBow Expandable Spacer System is an FDA 510(k)-cleared medical device (K170919) 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 August 2, 2017. Regulation: 8.