Code of Federal Regulations · Section
§ 888.3400 — Hip Joint Femoral (hemi-hip) Metallic Resurfacing Prosthesis
21 C.F.R. § 888.3400
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351