Panel highlights lack of support on safety, efficacy of spinal sphere devices for fusion (Healio)
In a meeting about the FDA's recommendation to categorize spinal sphere devices for use in fusion procedures as class III, the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee noted the risks of the product as identified by the FDA are adequate with the addition of a significant or unacceptable risk of revision.
The panel also held there are no reasonable assurances of safety or efficacy of these devices for this indication and agreed with the FDA's assessment...
