title: The process of FDA approval of a spinal implant: governmental perspective.
authors.affiliation: Office of Device Evaluation, Food and Drug Administration, Washington, DC.
authors.forename: T J
authors.initials: TJ
authors.lastname: Callahan
mesh_terms: D002986:Clinical Trials as Topic; D004869:Equipment Safety; D006801:Humans; D019736:Prostheses and Implants / Q000592:standards*; D013131:Spine / Q000601:surgery*; D014481:United States; D014486:United States Food and Drug Administration