Issue Date: 06/12/2007
Issued By: Office of Medical Products and Tobacco, Center for Devices and Radiological Health
This guidance document was developed as a special control guidance to support the reclassification of intervertebral body fusion devices that contain bone grafting material into class II (special controls). The 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. FDA is issuing this guidance in conjunction with a Federal Register (FR) notice announcing the final rule.