Precision Spine Interspinous Plate System

Precision Spine Interspinous Plate System is an FDA 510(k)-cleared medical device (K160568) manufactured by Precision Spine, 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 May 3, 2016. Regulation: 8.