JGH1 Bone Graft Substitute

JGH1 Bone Graft Substitute is an FDA 510(k)-cleared medical device (K181342) manufactured by AgNovos Healthcare USA, 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 July 18, 2018. Regulation: 8.