[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: 21CFR888.3060]

[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. 888.3060  Spinal intervertebral body fixation orthosis.

    (a) Identification. A spinal intervertebral body fixation orthosis 
is a device intended to be implanted made of titanium. It consists of 
various vertebral plates that are punched into each of a series of 
vertebral bodies. An eye-type screw is inserted in a hole in the center 
of each of the plates. A braided cable is threaded through each eye-type 
screw. The cable is tightened with a tension device and it is fastened 
or crimped at each eye-type screw. The device is used to apply force to 
a series of vertebrae to correct ``sway back,'' scoliosis (lateral 
curvature of the spine), or other conditions.
    (b) Classification. Class II.