FDA Final Order Requires PMA for Spinal Spheres

The FDA has issued a final order requiring the filing of a premarket approval (PMA) application for spinal spheres used in intervertebral fusion procedures as Class III devices.

Sponsors who wish to market the previously unclassified spinal sphere devices must file a PMA within the 30-month period following the April 19 effective date of the final order.

The agency said it intends to review any PMA for the devices within 180 days.