CoreLink Gets 510(k) Clearance for its CentraFix Midline Fixation System

St. Louis, Mo.-based CoreLink has received the FDA’s 510(k) clearance for its CentraFix fixation system, an addition to the company’s Pedicle screw system.

CentraFix features cobalt chrome heads and titanium-alloy screw shanks in various lengths and diameters, intended to allow screw placement in denser cortical bone.

The Pedicle system, which is designed for less-invasive spinal fixation procedures, can reduce incision size, limit muscular and vascular injury, and improve initial fixation, the company said.