510(k) for Spinal Concepts:
This article was originally published in Clinica
Executive Summary
The FDA has given Spinal Concepts the all-clear to market its titanium BacFix system, designed specifically for posterior correction and fixation of the thoracolumbar spine. The system features a snap-lock connector which is pre-assembled with the fixation component, thus reducing intraoperative time. Once implanted, the rods are snapped into place.