ZETA SURGICAL® Receives FDA 510(k) Clearance for Zeta Navigation System
ZETA SURGICAL has received FDA 510(k) clearance for its Zeta Navigation System and instruments, enabling enhanced guidance for neurosurgical procedures such as brain biopsies and the treatment of hydrocephalus and trigeminal neuralgia. This clearance is seen as a significant advancement, providing computer-assisted real-time image guidance, aimed at improving the precision of surgical interventions.
BOSTON, May 1, 2026 /PRNewswire/ — ZETA SURGICAL today announced that its Zeta Navigation System, alongside its navigated instruments, Zeta Stylet and Zeta Bolt, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II…