ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System

ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System is an FDA 510(k)-cleared medical device (K260549) manufactured by Zsfab, 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 April 23, 2026. Regulation: 8.