ACROMED BRANTIGAN SPINAL FIXATION CAGE/VSP PEDICLE SCREW COMBO NOT APPROVABLE DUE TO MATERIAL AND DESIGN CHANGES, PANEL CONCLUDES
This article was originally published in The Gray Sheet
Executive Summary
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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