Intelivation Technologies today announced that it has received FDA 510(k) clearance for its Golden Isles pedicle screw system.
The Saint Simons Island, Georgia-based company designed the Golden Isles system to provide immobilization and stabilization of spinal segments in skeletally mature patients to treat the lumbar and sacral spine. It is intended for use in posterior, non-cervical pedicle fixation in skeletally mature patients to treat degenerative disc disease, spondylolisthesis, trauma, deformities, pseudoarthrosis and failed previous fusions.
“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,” President Amit Sinha said in a news release.
“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,” said CEO Rob Anderson.