Zavation anterior cervical plate and spacer system gets FDA clearance

Carly Behm -  

Zavation Medical Products' Varisync system received FDA 510(k) clearance.

Varisync was tested and approved for the independent and synchronized use of its plate and spacer components, allowing surgeons to use them together or individually, according to an Aug. 18 news release from the devicemaker. The system is indicated for anterior screw fixation to the cervical spine for patients with degenerative disc disease, trauma, tumors, deformity, failed spinal fusions, spondylolisthesis and spinal stenosis.

"Our product development team's dedication to creatively blending simplicity and precision in a robust product design has produced a product that we believe is the new gold standard in facilitating patient fusion in a seamless and simplified procedure," Zavation CEO Jeffrey Johnson said in the release. "With the extensive interbody offerings that Zavation boasts, it only makes sense that we develop a device that allows surgeons to easily integrate and place a plate and spacer combination of their choice."

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