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FDA clears Spinal USA solo anterior cervical plate system

Precision Spine, the parent company of Spinal USA, has announced FDA 510(k) clearance of the Slimplicity solo anterior cervical plate system.

The Spinal USA’s Slimplicity new anterior cervical plate system, which consists of one and two level plates and 4.5mm fixed and variable screws, is designed to accommodate a visual locking confirmation with a secure locking mechanism and provides an ergonomic colour coded instrument set.

Precision Spine president Rich Dickerson said that Slimplicity Solo is the company’s third product launch in two years.

"This product will provide surgeons with an exciting new fixation system for the cervical spine, offering potential benefits over existing, traditional cervical plating systems," Dickerson added.

"We also believe this product will have application in the expanding same day surgery market segment."

The Solo system is proposed for anterior cervical fixation to the cervical spine C2-C7 for the indications such as degenerative disc disease, trauma (including fractures), tumours, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.