[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3040]

[Page 467]
 
                        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. 888.3040  Smooth or threaded metallic bone fixation fastener.

    (a) Identification. A smooth or threaded metallic bone fixation 
fastener is a device intended to be implanted that consists of a stiff 
wire segment or rod made of alloys, such as cobalt-chromium-molybdenum 
and stainless steel, and that may be smooth on the outside, fully or 
partially threaded, straight or U-shaped; and may be either blunt 
pointed, sharp pointed, or have a formed, slotted head on the end. It 
may be used for fixation of bone fractures, for bone reconstructions, as 
a guide pin for insertion of other implants, or it may be implanted 
through the skin so that a pulling force (traction) may be applied to 
the skeletal system.
    (b) Classification. Class II.