Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)

Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) is an FDA 510(k)-cleared medical device (K252597) manufactured by Alphatec Spine, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 18, 2026. Regulation: 8.