Zavation Medical Products has obtained 510k clearance from the US Food and Drug Administration (FDA) for its Varisync Anterior Cervical Plate and Spacer system.
The device is a new addition to the company’s cervical spine portfolio.
Varisync was tested and approved for independent and synchronised use of its plate and spacer components.
This allows surgeons to use the plate and spacer together or individually with any of the company’s other current cervical portfolio options.
The Varisync plate boasts attributes that include visual and tactile confirmation of locks, optimal spacer placement in the disc space, multiple insertion devices and ideal screw angulation.
It is designed for anterior screw fixation to the cervical spine for patients with deformity, spondylolisthesis, spinal stenosis, degenerative disc disease, trauma, tumours, failed spinal fusions and spinal stenosis.
Zavation Medical Products CEO Jeffrey Johnson said: “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.
“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.
“This product is an example of Zavation’s commitment to offering innovative and differentiated products in conjunction with market leading customer service to best serve our surgeons and distributor network.”
An interbody fusion device, Varisync Spacer has been designed for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at first level.
The spacer will be filled with autograft or allogenic bone graft, comprising cancellous and/or corticancellous bone graft, in skeletally mature patients.
Zavation Medical said that these devices are developed to be used along with supplemental fixation, including the Zavation Midline Plate, Zavation Varisync Plate, Zavation EZ Plate or Zavation Cervical Plate Systems.
The assembly takes on the indications of the Varisync Spacer when it is used with the Varisync Plate, which will serve as the supplemental fixation.
In June, Zavation Medical’s expandable lumbar interbody fusion device, eZspand Lateral, secured 510k clearance from the US FDA.