Cutting Edge Spine Gains FDA Clearance of EVOL-SI Joint Fusion

By Julie A. Vetalice

Cutting Edge Spine received FDA 510(k) clearance to market the EVOL-SI sacroiliac joint fusion system.

Surface modification on the device is intended to improve osseointegration through hydrophilicity and surface chemistry, while characteristic nano-roughness mediates bioactivity that affects tissue regeneration to yield early bone formation that supports mechanical stability.

Product launch is underway.

Cutting Edge Spine EVOL-SI Joint Fusion System - ORTHOWORLD

Source: Cutting Edge Spine


Tags: 510(k) Clearance, Regulatory