VySpine received a trio of FDA clearances for its products, providing increased diversity to its portfolio.
Among the devices announced is FDA clearance for additional connectors for the VySpan PCT system. These new connectors can be easily attached to the VyLink Screw System.
VySpine also received a 510(k) clearance for its VyLam System, which is indicated for use in laminoplasty of the lower cervical and upper thoracic spine in skeletally mature patients.
In addition, FDA has cleared 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 treatment for 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.”
VySpine received a trio of FDA clearances for its products, providing increased diversity to its portfolio.
Among the devices announced is FDA clearance for additional connectors for the VySpan PCT system. These new connectors can be easily attached to the VyLink Screw System.
VySpine also received a 510(k) clearance for its VyLam System,...
VySpine received a trio of FDA clearances for its products, providing increased diversity to its portfolio.
Among the devices announced is FDA clearance for additional connectors for the VySpan PCT system. These new connectors can be easily attached to the VyLink Screw System.
VySpine also received a 510(k) clearance for its VyLam System, which is indicated for use in laminoplasty of the lower cervical and upper thoracic spine in skeletally mature patients.
In addition, FDA has cleared 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 treatment for 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.”
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