ShurFit CpTi-HA ACIF Interbody Fusion System

ShurFit CpTi-HA ACIF Interbody Fusion System is an FDA 510(k)-cleared medical device (K161809) 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 December 5, 2016. Regulation: 8.