Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System

Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System is an FDA 510(k)-cleared medical device (K232530) manufactured by Nexus Spine, LLC. 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 17, 2023. Regulation: 8.