Zdrowie i gospodarka · 30/04/2002

FDA Reclassifies Hip Joint Metal/Polymer Prostheses from Class III to Class II

The FDA is reclassifying hip joint metal/polymer constrained cemented or uncemented prosthesis from a Class III device requiring premarket approval to a Class II device with special controls, following a reclassification petition from the Orthopedic Surgical Manufacturers Association, and is revising the device identification to better describe the device.