Wenzel Spine earned FDA clearance for the PrimaLOK SP system, the devicemaker said Aug. 22.
The device is designed for spinal fusion and can be used at multiple levels for patients with lumbar spinal stenosis, according to a news release. It has a locking mechanism for stabilization, high flexibility and is designed for minimal tissue disruption and improved radiographic visibility.
"This achievement reflects our ongoing commitment to innovation and excellence in our spinal solutions," CEO William Wilson said in the release. "We believe this system will significantly contribute to improved patient outcomes through a less invasive approach."