[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3400]

[Page 465-466]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 888--ORTHOPEDIC DEVICES--Table of Contents
 
                      Subpart D--Prosthetic Devices
 
Sec. 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

[[Page 466]]

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.