Stabilis SA Cervical Stand-Alone System (Various PNs)

Stabilis SA Cervical Stand-Alone System (Various PNs) is an FDA 510(k)-cleared medical device (K251735) manufactured by Acuity Surgical Devices, 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 July 29, 2025. Regulation: 8.