-

VySpine Announces FDA Clearances for VySpan, VyLam and VySpine Innovations

Trio of Clearances Expands VySpine’s Growing Product Portfolio

TALLAHASSEE, Fla.--(BUSINESS WIRE)--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.”

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.com

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

Contacts

Paul Williams, 310-569-0023, paul@medialinecommunications.com

VySpine


Release Versions

Contacts

Paul Williams, 310-569-0023, paul@medialinecommunications.com

More News From VySpine

Vy Spine Announces FDA Clearance of 3D Printed LumiVy OsteoVy PEKK Lumbar IBF

BOUNTIFUL, Utah--(BUSINESS WIRE)--Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its LumiVy OsteoVy PEKK Lumbar IBF. The device is indicated for intervertebral body fusion for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. The LumiVy OsteoVy PEKK...

Vy Spine Announces FDA Clearance for its ClariVy OsteoVy PEKK Cervical IBF

TALLAHASSEE, Fla.--(BUSINESS WIRE)--Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD). The novel ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the...

VySpine Announces FDA Clearance for UniVy OsteoVy-Ti Cervical IBF with NanoVy-HA

TALLAHASSEE, Fla.--(BUSINESS WIRE)--VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System which is indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD). The UniVy OsteoVy-Ti NanoVy-HA Cervical IBF System features VySpine's NanoVy-HA technology in partn...
Back to Newsroom