SpineUp has been granted 510(k) clearance by the US Food and Drug Administration (FDA) for both its Romero self-anchored cervical cage and Romero cervical cage—the company’s first product range.
The Romero self-anchored cervical cage and Romero cervical cage are made of PEEK-Optima HA Enhanced which is designed to enable greater osteointegration than traditional polyetheretherketone (PEEK).
Philippe Laurito, SpineUp founder, said: “We are thrilled to receive the first 510(k) of the company, especially after the challenging past two years. This clearance represents not only the achievement of years of work but is also a promise for the future. We, at SpineUp, are convinced that the PEEK HA-Enhanced technology as well as the 3D titanium printed technology are the right path for the future of spine surgery.”