NGMedical was granted FDA 510(k) clearance to market its BEE® HA (hydroxyapatite) cervical interbody, made of PEEK-OPTIMA™ HA Enhanced from Invibio Biomaterial Solutions, a global leader in high-performance biomaterial solutions.
BEE HA was designed to optimize fusion while maintaining elasticity that is similar to bone and radiolucency of the cage body. HA is fully integrated into the PEEK-OPTIMA matrix, making it available on all surfaces of the finished device.
"This is the next step for NGMedical to broaden our active market presence in the USA. We are proud having received the FDA clearance for our new BEE® HA. Our team did a great job in cooperation with MRC Global," says Dagmar Weiland, CEO of NGMedical.