Medical devices; reclassification and codification of hip joint metal polymer/metal semi-constrained porous-coated uncemented prosthesis--FDA. Final rule.

  • Published 1993 in Federal register


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… (More)


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