Intelivation Technologies has announced that the company has achieved US Food and Drug Administration (FDA) 510(k) clearance of its Golden Isles Pedicle Screw System.
The Golden Isles Pedicle Screw System is designed to provide immobilisation and stabilisation of spinal segments in skeletally mature patients in treating the lumbar and sacral spine.
The system is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for treating degenerative disc disease, spondylolisthesis, trauma, deformities as well as pseudoarthrosis and failed previous fusions.
Intelivation Technologies president, Amit Sinha, said: “The modularity of the Golden Isles Pedicle Screw System enables the surgeon greater versatility, efficiency, and visibility to achieve superior patient outcomes for the most difficult degenerative and traumatic procedures.”
Rob Anderson, CEO, added: “The simplicity of the system along with the strength of the tulip and screw interface is unsurpassed compared to other options that are currently available on the market.”