OptiMesh Multiplanar Expandable Interbody Fusion System

OptiMesh Multiplanar Expandable Interbody Fusion System is an FDA 510(k)-cleared medical device (K251302) manufactured by Spineology, 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 December 14, 2025. Regulation: 8.