PFX SPINOUS PROCESS FIXATION SYSTEM

PFX SPINOUS PROCESS FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K132765) manufactured by Innovasis, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2014. Regulation: 8.