UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)

UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) is an FDA 510(k)-cleared medical device (K132968) manufactured by Stryker Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2013. Regulation: 8.