Endoskeleton™ Interbody Systems

Endoskeleton™ Interbody Systems is an FDA 510(k)-cleared medical device (K251444) manufactured by Medtronic Sofamor Danek USA, 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, 2025. Regulation: 8.