DEPUY SYNTHES SPINE DENS ACCESS SYSTEM

DEPUY SYNTHES SPINE DENS ACCESS SYSTEM is an FDA 510(k)-cleared medical device (K132910) manufactured by Synthes USA Products, LLC. 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 15, 2013. Regulation: 8.