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Transcript Published for FDA Orthopaedic and Rehabilitation Devices Panel on Spinal Spheres

FDA's Orthopaedic and Rehabilitation Devices Panel has published its transcript from the meeting regarding the classification of spinal sphere devices. The meeting occurred on December 12, 2013. Based on the information collected and materials presented, FDA recommends that spinal sphere devices for use in arthrodesis procedures be regulated as Class III devices requiring a PMA.

The devices are manufactured from metallic or polymeric materials and designed for insertion between vertebral bodies from L3-S1 to promote fusion and stabilization, and are presently regulated under Product Code NVR.

View the full transcript here.