[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3010]

[Page 495]
 
                        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. 888.3010  Bone fixation cerclage.

    (a) Identification. A bone fixation cerclage is a device intended to 
be implanted that is made of alloys, such as cobalt-chromium-molybdenum, 
and that consists of a metallic ribbon or flat sheet or a wire. The 
device is wrapped around the shaft of a long bone, anchored to the bone 
with wire or screws, and used in the fixation of fractures.
    (b) Classification. Class II.