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Home » FDA clears VySpine’s VyPlate anterior cervical plate system

FDA clears VySpine’s VyPlate anterior cervical plate system

August 17, 2022 By Danielle Kirsh

VySpine VyPlate
VyPlate stabilizes the anterior cervical spine from C2 to C7. [Image courtesy of VySpine]
VySpine this week announced it received FDA 510(k) clearance for its VyPlate anterior cervical plate system.

Tallahassee, Florida-based VySpine designed VyPlate to stabilize the anterior cervical spine from C2 to C7 by using unicortical screw fixation at the anterior face the vertebral bodies.

The system has plates and screws that are manufactured from titanium alloy as specified by ASTM F-136. The locking mechanism ensures that the bone screws are fully captured within the system.

“The VyPlate ACP System is a unique, elegantly simple system,” CEO Tom McLeer said in a news release. “It offers a great deal of versatility and flexibility while providing ease of use for the surgeon. The VyPlate is intuitive while also being robust and adaptable.”

VyPlate comes in numerous sizes, ranging from a single-level to five-level plates. The boy screws can be variable with a high degree of angulation or in a fixed angle to the plate. The system’s bone screws are also available in self-drilling or self-tapping configuration and come in a range of lengths and diameters to provide an optimal fit for unique patient anatomies.

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance, Spine Tagged With: VySpine

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About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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