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21 C.F.R. § 888.3400   Hip joint femoral (hemi-hip) metallic resurfacing prosthesis.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

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§ 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.

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