Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart D - Prosthetic Devices / § 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
§ 888.3400 Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.
(a) Identification. A hip joint femoral (hemi-hip) metallic resurfacing prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral resurfacing component made of alloys, such as cobalt-chromium-molybdenum.
(b) Classification. Class II.