Spineology received FDA 510(k) clearance to market the Rampart™ Duo™ Interbody Fusion System, reportedly the first device to combine PEEK, titanium and graft containment mesh elements.
The design includes PEEK spacer blocks at each end of the device and a flexible porous graft containment mesh.
In 3Q16, the company received FDA clearance for use of allograft bone with Rampart Interbody Fusion Devices.
Sources: Spineology; ORTHOWORLD Inc.