Intelivation Technologies Gains FDA 510(k) for Golden Isles Pedicle Screw

By Julie A. Vetalice

Intelivation Technologies Gains FDA 510(k) for Golden Isles Pedicle Screw

Intelivation Technologies was granted FDA 510(k) clearance to market the Golden Isles Pedicle Screw™.

The modular system is designed to provide immobilization and stabilization of spinal segments in skeletally mature patients in treating the lumbar and sacral spine. It 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.

Golden Isles showcases both standard and reduction tulips along with a comprehensive set of insertion and reduction instruments. Product launch will occur in late 3Q21.

Source: Intelivation Technologies

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory