Vital™ Spinal Fixation System

Vital™ Spinal Fixation System is an FDA 510(k)-cleared medical device (K253093) manufactured by Highridge Medical, 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 December 16, 2025. Regulation: 8.