Cutting Edge Spine Announces FDA 510(K) Clearance of its New HA Enhanced PEEK Interbody System for a Direct Lateral Approach to the Spine, the EVOL®ha-DLIF
Cutting Edge Spine, a leader in the development and commercialization of bioactive spinal solutions, today announced the 510(K) clearance and commercial launch of the latest addition to its bioactive portfolio of interbody systems, the EVOL®ha-DLIF direct lateral interbody fusion system.
The EVOL®ha-DLIF is made of PEEK-OPTIMA HA Enhanced material supplied by Invibio Biomaterial Solutions. Cutting Edge Spine 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.”
In addition to the EVOL®ha-DLIF, Cutting Edge Spine offers numerous other interbody fusion systems made with the PEEK-OPTIMA HA Enhanced material: EVOL®ha-C, EVOL®ha-ALIF, EVOS®ha.
About Cutting Edge Spine
Founded in 2009, Cutting Edge Spine (CES) is a privately-owned medical device organization, headquartered in Waxhaw, NC. The Company is dedicated to developing and commercializing a novel, comprehensive portfolio of bioactive spinal interbody fusion systems and providing optimal fiscal value to patients, payors and healthcare providers. The Company currently possesses seven 510(K) cleared proprietary technologies and plans to add several more in 2020. For more information please contact our team at Cutting Edge Spine.