[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: 21CFR888.3170]

[Page 479]
 
                        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. 888.3170  Elbow joint radial (hemi-elbow) polymer prosthesis.

    (a) Identification. An elbow joint radial (hemi-elbow) polymer 
prosthesis is a device intended to be implanted made of medical grade 
silicone elastomer used to replace the proximal end of the radius.
    (b) Classification. Class II.