VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received a trio of U.S. Food and Drug Administration (FDA) clearances for its products, providing increased diversity to the company’s portfolio.
Among the approvals announced is FDA clearance for additional connectors for the VySpan PCT system to add to its versatility. These new, robust connectors can be easily attached to the VyLink Screw System.
VySpine also received a 510(k) clearance from the FDA for its VyLam System, which is indicated for use in laminoplasty of the lower cervical and upper thoracic spine (C3-T3) in skeletally mature patients.
In addition, the FDA has approved additional indications for VySpine’s VyLink Screw System. The VyLink Screw, when used in the sacroiliac joint, is intended for the emerging market of sacroiliac joint fusion, allowing surgeons to provide an alternative way to treat patients with sacroiliac joint dysfunction.
“Receiving this series of three FDA clearances in quick succession not only marks a major step in our company’s development,” said Bret Berry, VySpine’s President of Product Development, “it also helps bring a heightened level of flexibility to the spine surgery community. Using new materials and creative surgeon input, we also continue to build exceptional quality and pricing into all our products. This is the just the beginning of the exciting, innovative product launches we have scheduled for early 2024.”