NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY

NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY is an FDA 510(k)-cleared medical device (K102722) 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 January 26, 2011. Regulation: 8.