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FDA Proposal for the reclassification of the Intervertebral body fusion device Regulatory History of the Intervertebral Body Fusion Device (Cage): The intervertebral body fusion device (cage) was first marketed in the United States, after the Medical Device Amendments of 1976 (the 1976 Amendments) to the Food, Drug and Cosmetic Act (the Act) (21 USC 360C) as Class III, post-amendments devices requiring an approved Premarket Approval Application prior to marketing.? ? The 1976 Amendments as amended by the Safe Medical Device Act (SMDA) of 1990 and the FDA Modernization Act (FDAMA) of 1997 prov