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VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations 

Trio of Clearances Expands VySpine’s Growing Product Portfolio   

Tallahassee, FL – October 17, 2023VySpine, 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. 

VyLam laminoplasty plate

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.

VyLink SI shown in SI joint fixation rod construct

“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.”  

About VySpine 

VySpine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. This comprehensive line of core spine products and newly developed specialty products allow us to meet the needs of both health care providers and surgeons. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at 

“VySpine,” “VySpan,” “VyLink,” and “VyLam,” are registered trademarks of VySpine. 

Media Contact:
Paul Williams
MediaLine Communications

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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