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FDA Grants Clearances for VySpan, VyLam, and VySpine's Latest Healthcare Innovations

Wednesday, October 18, 2023

VySpine, a leader in spinal innovation known for its unique materials and design strategies, made an announcement today regarding three newly acquired FDA clearances for its product lineup. These clearances expand and diversify the company's product portfolio. Notably, one of these approvals pertains to enhanced connectors for the VySpan PCT system, boosting its versatility.

These robust connectors can be conveniently affixed to the VyLink Screw System. Additionally, the FDA has granted a 510(k) clearance for VySpine's VyLam System, designed for use in laminoplasty procedures on the lower cervical and upper thoracic spine (C3-T3) in adult patients.

Furthermore, the FDA has extended its approvals to encompass additional applications for VySpine's VyLink Screw System. When utilized in the sacroiliac joint, the VyLink Screw provides a valuable option for the growing sacroiliac joint fusion market, offering an alternative for treating patients with sacroiliac joint dysfunction. VySpine's President of Product Development emphasized that these advancements introduce an elevated level of flexibility to the spine surgery community.

Source: businesswire.com

 

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