Surgalign Gets FDA 510(k) Clearance For Spinal Fixation System

Surgalign Holdings SRGA announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Cortera Spinal Fixation System.

Cortera is a 5.5/6.0mm rod pedicle screw system, that has both open and MIS modules. The system boasts a feature-rich screw design that maintains a comparatively low profile and a newly designed locking mechanism.

This new front runner product is a key piece to the foundational portfolio designed to drive Surgalign's future growth over the next 10 years and to enable market share gains in the estimated $2.2B US posterior fixation market.

The company noted that the Cortera system was strategically designed to maximize adoption in the spine market and for the future of evolving techniques and technology.

Terry Rich, President and CEO, said, "The Cortera system is a testament to the spine engineering talent and expertise we've assembled in very short order, as we moved from zero engineers in the United States. We are excited with the prospects the Cortera system brings to Surgalign, and those around the world who rely on our technology to drive better patient outcomes.”

Surgalign assumes that Cortera will help accelerate adoption of the HOLO Portal surgical guidance system by offering surgeons and hospitals two state-of-the-art technologies packaged together to perform spinal fusion procedures.

Price Action : Surgalign shares are trading around 1 percent higher at $4.24 on Wednesday at the time of publication.