21 CFR § 888.3060 - Spinal intervertebral body fixation orthosis.

---
identifier: "/us/cfr/t21/s888.3060"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3060 - Spinal intervertebral body fixation orthosis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3060"
section_name: "Spinal intervertebral body fixation orthosis."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "888"
part_name: "ORTHOPEDIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "52 FR 33702, Sept. 4, 1987, unless otherwise noted."
cfr_part: "888"
---


# 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.