Ellipse Technologies announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the MAGEC Spinal Bracing and Distraction System.
The MAGEC system is a growth-friendly solution for pediatric patients with severe progressive spinal deformities associated with thoracic insufficiency syndrome. These deformities typically require repeated lengthening surgeries throughout the child's growing years.
The system has been used by more than 150 surgeons in 24 countries, thus far.
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