VySpine has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VyPlate anterior cervical plate (ACP) system. The VyPlate ACP system is indicated for stabilization of the anterior cervical spine from C2 to C7, employing unicortical screw fixation at the anterior face of the vertebral bodies.
The VyPlate ACP system features plates and screws manufactured from titanium alloy (as specified by ASTM F-136). The system’s robust yet simple locking mechanism ensures that the bone screws are fully captured within the VyPlate, say the company.
Tom McLeer, CEO of VySpine, said: “The VyPlate ACP system is a unique, elegantly simple system. 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.”
The system comes in numerous sizes, ranging from single-level to five-level plates. The bone screws can either be variable or in a fixed angle to the plate. Additionally, the VyPlate bone screws are available in self-drilling or self-tapping configurations.
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