[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR888.3230]

[Page 462]
 
                        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. 888.3230  Finger joint polymer constrained prosthesis.

    (a) Identification. A finger joint polymer constrained prosthesis is 
a device intended to be implanted to replace a metacarpophalangeal or 
proximal interphalangeal (finger) joint. This generic type of device 
includes prostheses that consist of a single flexible across-the-joint 
component made from either a silicone elastomer or a combination pf 
polypropylene and polyester material. The flexible across-the-joint 
component may be covered with a silicone rubber sleeve.
    (b) Classification. Class II.