FDA Clears Surgalign’s Cortera Spinal Fixation System

The FDA has granted 510(k) marketing clearance to Surgalign’s newly designed Cortera spinal fixation system.

The new flagship product will be integrated with the company’s HOLO Portal surgical guidance software that delivers an interactive display and a 3D overlay on the patient's anatomy.

Cortera is a 5.5/6.0mm rod pedicle screw system that maintains a comparatively low profile and includes a new locking mechanism.

Surgalign CEO Terry Rich said the company aims to expand the system with other implants and instruments over the next three to four years.