---
kind: "section"
citation: "21 C.F.R. § 888.3060"
title: "21"
number: "888.3060"
heading: "Spinal intervertebral body fixation orthosis."
url: "https://uscodex.org/cfr/21/888.3060"
---

# §888.3060. Spinal intervertebral body fixation orthosis.

- (a) **Identification.** A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.
- (b) **Classification.** Class II.

## Notes

### 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.