Eminent Spine earned FDA 510(k) clearance for its 3D-printed titanium pedicle screw system, according to a May 7 news release.
The milestone makes it the first and only system of its kind to earn FDA clearance, and it is made from 100% 3D-printed titanium. Screw sizes are available in 6.0mm, 6.5mm, 7.0mm, 7.5mm, and 8.0mm diameters and 40mm and 60mm lengths.
“Our mission has always been to innovate with purpose, and this clearance validates years of research, development, and surgeon collaboration,” Stephen Courtney, MD, CEO of Eminent Spine, said in the release.
