Zdrowie i gospodarka · 15/12/2021

FDA Proposes Classification of Spinal Spheres for Intervertebral Fusion Procedures

The US Food and Drug Administration (FDA) is proposing to classify spinal spheres used in spinal fusion procedures into Class III, requiring a premarket approval application, due to concerns over safety and effectiveness, following recommendations from the Orthopaedic and Rehabilitation Devices Panel.