[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: 21CFR888.3030]

[Page 457]
 
                        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. 888.3030  Single/multiple component metallic bone fixation appliances and accessories.

    (a) Identification. Single/multiple component metallic bone fixation 
appliances and accessories are devices intended to be implanted 
consisting of one or more metallic components and their metallic 
fasteners. The devices contain a plate, a nail/plate combination, or a 
blade/plate combination that are made of alloys, such as cobalt-
chromium-molybdenum, stainless steel, and titanium, that are intended to 
be held in position with fasteners, such as screws and nails, or bolts, 
nuts, and washers. These devices are used for fixation of fractures of 
the proximal or distal end of long bones, such as intracapsular, 
intertrochanteric, intercervical, supracondylar, or condylar fractures 
of the femur; for fusion of a joint; or for surgical procedures that 
involve cutting a bone. The devices may be implanted or attached through 
the skin so that a pulling force (traction) may be applied to the 
skeletal system.
    (b) Classification. Class II.

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