Sam Brusco, Associate Editor10.18.23
VySpine has gained a trio of U.S. Food and Drug Administration (FDA) clearances for its products:
The new connectors can also be “easily attached” to the Vylink screw system, according to the company. The VyLink screw, when used in the sacroiliac (SI) joint, is for the emerging SI joint fusion market, allowing surgeons an alternative way to treat SI dysfunction patients.
“Receiving this series of three FDA clearances in quick succession not only marks a major step in our company’s development,” Bret Berry, VySpine’s president of product development told the press. “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.”
- Clearance for additional connectors for the VySpan PCT system to add to its versatility
- 510(k) for the VyLam system, which is used for C3-T3 laminoplasty in skeletally mature patients
- Approval of more indications for the VyLink screw system
The new connectors can also be “easily attached” to the Vylink screw system, according to the company. The VyLink screw, when used in the sacroiliac (SI) joint, is for the emerging SI joint fusion market, allowing surgeons an alternative way to treat SI dysfunction patients.
“Receiving this series of three FDA clearances in quick succession not only marks a major step in our company’s development,” Bret Berry, VySpine’s president of product development told the press. “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.”