[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: 21CFR888.3080]

[Page 497]
 
                        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. 888.3080  Intervertebral body fusion device.

    (a) Identification. An intervertebral body fusion device is an 
implanted single or multiple component spinal device made from a variety 
of materials, including titanium and polymers. The device is inserted 
into the intervertebral body space of the cervical or lumbosacral spine, 
and is intended for intervertebral body fusion.
    (b) Classification. (1) Class II (special controls) for 
intervertebral body fusion devices that contain bone grafting material. 
The special control is the FDA guidance document entitled ``Class II 
Special Controls Guidance Document: Intervertebral Body Fusion Device.'' 
See Sec. 888.1(e) for the availability of this guidance document.
    (2) Class III (premarket approval) for intervertebral body fusion 
devices that include any therapeutic biologic (e.g., bone morphogenic 
protein). Intervertebral body fusion devices that contain any 
therapeutic biologic require premarket approval.
    (c) Date premarket approval application (PMA) or notice of product 
development protocol (PDP) is required. Devices described in paragraph 
(b)(2) of this section shall have an approved PMA or a declared 
completed PDP in effect before being placed in commercial distribution.

[72 FR 32172, June 12, 2007]