"Substantially equivalent": the FDA, orthopedic device manufacturer, and you.
Shaw
James A
JA
Orthopedic Consultations, Cabin John, Maryland 20818, USA.
D006801:Humans; D007595:Joint Prosthesis / Q000145:classification / Q000592:standards*; D011358:Product Surveillance, Postmarketing; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration