Intelivation Technologies Gets FDA’s 510(k) Clearance for Pedicle Screw System
Georgia-based Intelivation Technologies has received the FDA’s 510(k) clearance for its Golden Isles pedicle screw system.
The system, which is designed to stabilize spinal segments in skeletally mature patients, is cleared for use in treating degenerative disc disease, spondylolisthesis, trauma and deformities, as well as pseudoarthrosis and failed previous fusions.
The system’s modularity offers surgeons greater versatility for difficult degenerative and traumatic procedures, Intelivation said. The company plans to launch the product in the U.S. market in late September.