Cutting Edge Spine Gains FDA Clearance of EVOLha-DLIF

By Julie A. Vetalice

Cutting Edge Spine Gains FDA Clearance of EVOLha-DLIF

Cutting Edge Spine (CES) received FDA 510(k) clearance of the EVOL®ha-DLIF direct lateral interbody fusion system, its latest addition to a bioactive device portfolio. Product launch is underway.

Like the company's EVOLha-C, EVOLha-ALIF and EVOSha, EVOLha-DLIF is made of PEEK-OPTIMA HA Enhanced material from Invibio Biomaterial Solutions. CES implants made with this material have demonstrated early onset bone formation and apposition to its implants.

“Leveraging our expertise with the PEEK-OPTIMA HA Enhanced material as applied to interbody systems development and clinical validation is paving the way for Cutting Edge Spine to offer the largest worldwide bioactive interbody fusion system portfolio,” said Randy Roof, President, CEO & Founder of Cutting Edge Spine. “Maintaining a concentrated focus on the development and commercialization of novel bioactive interbody fusion solutions is at our core as a company, and we believe that is how we can best serve patients and surgeons on a global scale.”

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory