Zavation Receives 510(k) Clearance for Varisync Device

Flowood, Miss.-based Zavation Medical Products has received 510(k) clearance from the FDA for its Varisync cervical intervertebral body fusion device.

The latest addition to the company’s cervical spine portfolio, Varisync includes plate and spacer components that enable surgeons to use them together or to use individual components with the company’s other cervical products.

The plate is cleared for fixation to the cervical spine for treatment of degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusion, spondylolisthesis and spinal stenosis.

The spacer is intended for use in skeletally mature patients with degenerative disc disease of the cervical spine who have had at least six weeks of non-operative treatment.