21 CFR § 888.3050 - Spinal interlaminal fixation orthosis.

---
identifier: "/us/cfr/t21/s888.3050"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 888.3050 - Spinal interlaminal fixation orthosis."
title_number: 21
title_name: "Food and Drugs"
section_number: "888.3050"
section_name: "Spinal interlaminal 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"
---


# 888.3050 Spinal interlaminal fixation orthosis.

(a) *Identification.* A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

(b) *Classification.* Class II.