---
kind: "section"
citation: "21 C.F.R. § 888.3080"
title: "21"
number: "888.3080"
heading: "Intervertebral body fusion device."
url: "https://uscodex.org/cfr/21/888.3080"
---

# §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 [§ 888.1(e)](/cfr/21/888.1.md?p=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)](#b-2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

## Notes

### Amendments

[72 FR 32172, June 12, 2007]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

### Amendments

[72 FR 32172, June 12, 2007]