# Orthopedic Devices; Reclassification of the Intervertebral Body Fusion Device
> **Food and Drug Administration** · Final rule. · Published 2007-06-12 · 72 FR 32170
## Document
- **Document number:** E7-11240
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 72 FR 32170
- **CFR reference:** 21 CFR 888
- **Publication date:** 2007-06-12
- **HHS docket:** Docket No. 2006N-0019
## Abstract

The Food and Drug Administration (FDA) is reclassifying intervertebral body fusion devices that contain bone grafting material, from class III (premarket approval) into class II (special controls), and retain those that contain any therapeutic biologic (e.g., bone morphogenic protein) in class III. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. This reclassification is based upon on the recommendation of the Orthopaedic and Rehabilitation Devices Panel (the Panel).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2007/06/12/E7-11240/orthopedic-devices-reclassification-of-the-intervertebral-body-fusion-device)
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