CoreSpine Technologies, a Minneapolis-based spinal device developer, announced it has received 510(k) clearance to market from the U.S. Food and Drug Administration (FDA) for its XTEND-ST Nucleus Removal System.
“The clearance of the XTEND-ST device is truly a significant achievement for CoreSpine,” said Christine Horton, Chief Executive Officer of CoreSpine Technologies. “The XTEND-ST is a safe and effective device for removing lumbar disc material and satisfies a large unmet need within the spine industry. Of equal significance is that CoreSpine was able to develop the product with minimal funding over the past three years. I credit the many dedicated and talented medical device professionals that work with CoreSpine and the company’s ability to operate lean yet with a defined purpose.”
“The need for CoreSpine’s technology increases as additional spinal implants and new approaches are introduced to spine surgeons,” said John Sherman, M.D., spine surgeon with Twin Cities Orthopedics in Minneapolis, Minnesota. Dr. Sherman continued, “I continue to be impressed with the company’s history of developing new technology with limited funds.”
Source: CoreSpine Technologies