Medical devices; reclassification and codification of hip joint metal polymer/metal semi-constrained porous-coated uncemented prosthesis--FDA. Final rule.
The Food and Drug Administration (FDA) is announcing the reclassification and codification of the hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. FDA issued an order in the form of a letter to two manufacturers reclassifying the device from class III into class II. Accordingly, FDA is amending the regulations as set forth below.
D004869:Equipment Safety / Q000592:standards*; D006622:Hip Prosthesis / Q000145:classification*; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration