California spinal devices maker Aurora Spine touted a pair of FDA wins, landing clearance for additional sizes of its ZIP ULTRA spinal fusion system and additional clearance for the company’s ZIP MIS.
FDA regulators cleared the 35mm and 40mm sizes of the ZIP ULTRA device, a minimally invasive spinal fixation device designed as an alternative to pedicle screws. The device’s proprietary one-step locking mechanism precludes the need for screws, according to the company’s website.
Aurora also won clearance for its sterile-packed ZIP MIS, an achievement that president & CEO Trent Northcutt called "a testament to the ongoing dedication and perseverance of our team."
"The receipt of these additional FDA 510(k) clearances for our ZIP Ultra and ZIP MIS Interspinous Fusion System is another key milestone for Aurora Spine and allows us to expand our spinal product portfolio in the U.S. and key global markets," Northcutt said.
The company just earlier this year won FDA clearance for its TiNano implants for spinal fusion procedures.