Fortilink Cages with TiPlus Technology

Fortilink Cages with TiPlus Technology is an FDA 510(k)-cleared medical device (K201453) manufactured by Paradigm Spine GmbH. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 6, 2020. Regulation: 8.