SpineUp Gains FDA Clearance for Romero Cervical Cages

By Julie A. Vetalice

SpineUp Gains FDA Clearance for Romero Cervical Cages

SpineUp was granted FDA 510(k) clearance to market the Romero™ cervical cage and self-anchored cervical cage.

The devices are made of PEEK Optima HA-Enhanced, which enables osteointegration as an alternative to traditional PEEK.

This represents SpineUp's first product range.

Philippe Laurito, SpineUp Founder and Leader, 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 3D Titanium-printed technology are the right path for the future of spine surgery."

Source: SpineUp

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory