[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3050]

[Page 476]
 
                        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. 888.3050  Spinal interlaminal fixation orthosis.

    (a) Identification. A spinal interlaminal fixation orthosis is a 
device intended to be implanted made of an alloy, such as stainless 
steel, that consists of various hooks and a posteriorly placed 
compression or distraction rod. The device is implanted, usually across 
three adjacent vertebrae, to straighten and immobilize the spine to 
allow bone grafts to unite and fuse the vertebrae together. The device 
is used primarily in the treatment of scoliosis (a lateral curvature of 
the spine), but it also may be used in the treatment of fracture or 
dislocation of the spine, grades 3 and 4 of spondylolisthesis (a 
dislocation of the spinal column), and lower back syndrome.
    (b) Classification. Class II.