ACROMED BRANTIGAN SPINAL FIXATION CAGE/VSP PEDICLE SCREW COMBO NOT APPROVABLE DUE TO MATERIAL AND DESIGN CHANGES, PANEL CONCLUDES
Acromed's premarket approval application for the Brantigan interbody spinal fusion cage with VSP pedicle plate/screw system is not approvable because of post-PMA submission modifications in device design and material composition, FDA's Orthopedic and Rehabilitation Devices Advisory Panel decided by a 7-1 vote at its Dec. 11 meeting in Bethesda, Maryland.
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