Titan Spine Receives CE Mark Certification for Endoskeleton(R) Lumbar Interbody Fusion Devices
Published: Apr 05, 2011
“Obtaining the CE Mark on our lumbar systems is a significant milestone for our company,” commented Kevin Gemas, President of Titan Spine. “This will allow us to aggressively market our titanium surface technology in Europe, where the $160 Million-dollar interbody marketplace is trending towards titanium at a rate that even exceeds that of the United States. In addition, we plan to obtain CE Mark Certification on our cervical product line in the near future to further increase our addressable market in Europe.”
Scott Van Ells, Senior Quality Assurance & Regulatory Affairs Director for Titan Spine, spearheaded the project. “The timeframe in which we were able to accomplish the CE Mark accreditation speaks volumes to our Quality Management System and the efforts of the entire organization,” he stated. “The flexibility in allowing for a dynamic exchange of ideas to ensure that all domestic regulatory requirements are maintained while including additional requirements for the European Union was vital to the success of this project.”
About the Company – Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Founded in 2005, the company is committed to advancing the science of titanium surface engineering to enhance the treatment of various pathologies of the spine that require fusion.
Titan Spine Andrew Shepherd, 866-822-7800 www.titanspine.com