BONGOLD BONE GRAFT MATERIAL

BONGOLD BONE GRAFT MATERIAL is an FDA 510(k)-cleared medical device (K141725) manufactured by Beijing Allgens Medical Science & Technology Co, L. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 2015. Regulation: 8.