Trio of Clearances Expands VySpine’s Rising Product Portfolio
Tallahassee, FL – October 17, 2023—VySpine, a spine innovation chief utilizing differentiated supplies and designs, introduced immediately that it has obtained a trio of U.S. Food and Drug Administration (FDA) clearances for its merchandise, offering elevated range to the corporate’s portfolio.
Among the many approvals introduced is FDA clearance for added connectors for the VySpan PCT system so as to add to its versatility. These new, sturdy connectors might be simply hooked up to the VyLink Screw System.
VySpine additionally obtained a 510(ok) clearance from the FDA for its VyLam System, which is indicated to be used in laminoplasty of the decrease cervical and higher thoracic spine (C3-T3) in skeletally mature sufferers.
VyLam laminoplasty plate
As well as, the FDA has authorized extra indications for VySpine’s VyLink Screw System. The VyLink Screw, when used within the sacroiliac joint, is meant for the rising market of sacroiliac joint fusion, permitting surgeons to offer another approach to deal with sufferers with sacroiliac joint dysfunction.
VyLink SI proven in SI joint fixation rod assemble
“Receiving this sequence of three FDA clearances in fast succession not solely marks a significant step in our firm’s improvement,” mentioned Bret Berry, VySpine’s President of Product Improvement, “it additionally helps convey a heightened degree of flexibility to the spine surgical procedure neighborhood. Utilizing new supplies and inventive surgeon enter, we additionally proceed to construct distinctive high quality and pricing into all our merchandise. That is the just the start of the thrilling, progressive product launches we now have scheduled for early 2024.”
VySpine was created by means of energetic inner improvement and the licensing of assorted confirmed applied sciences utilizing progressive supplies and designs. This complete line of core spine merchandise and newly developed specialty merchandise enable us to fulfill the wants of each well being care suppliers and surgeons. The corporate strives to outpace the competitors by collaborating with key spine innovators whereas offering a versatile, cost-effective strategy to spine care. Be taught extra at vyspine.com
“VySpine,” “VySpan,” “VyLink,” and “VyLam,” are registered emblems of VySpine.
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