Varisync, the latest cervical spine product from Zavation, has undergone testing and received approval for both independent and synchronised use of its plate and spacer components
2-hole and 4-hole Varisync Plate. (Credit: PR Newswire/ Zavation Medical Products, LLC.)
Spinal implant maker Zavation Medical Products has announced FDA 510K clearance for its Varisync anterior cervical plate and spacer system.
Varisync, the latest cervical spine product from Zavation, has undergone testing and received approval for both independent and synchronised use of its plate and spacer components.
This enables the surgeon to combine these plate and spacer alternatives as a system or match individual components with any of the currently available cervical portfolio options from Zavation.
VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for degenerative disc disease, trauma, tumours, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.
VariSync Spacer is an interbody fusion tool designed for individuals with cervical degenerative disc degeneration (C2-T1) at one level who are skeletally mature.
According to the firm, the system can be used with the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems.
When utilised with the VariSync Plate, the assembly adopts the VariSync Spacer’s indications, with the VariSync Plate serving as an additional fixation.
It offers features like excellent screw angulation, numerous insertion devices, visual and tactile confirmation of locks, and the best spacer placement in the disc area.
Zavation Medical chief executive officer 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.”