Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System is an FDA 510(k)-cleared medical device (K232586) manufactured by K&J Consulting Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2023. Regulation: 8.