Intelivation Technologies, a medical device company with a cutting-edge spinal implant product portfolio announced today that they have achieved FDA 510(k) Clearance of the Golden Isles Pedicle Screw System™.
The Golden Isles Pedicle Screw System™ is designed to provide immobilization and stabilization 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.
President Amit Sinha remarked, “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.”
CEO Rob Anderson 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.”
Golden Isles showcases both standard and reduction tulips along with a comprehensive set of insertion and reduction instruments. The Management Team looks forward to a successful launch during the 36th Annual NASS Meeting in Boston September 29-Ocotber 2, 2021.