NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER

NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER is an FDA 510(k)-cleared medical device (K023862) manufactured by Synthes (Usa). 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 18, 2002. Regulation: 8.