{"data":{"id":"us/21-cfr-888.3060","jurisdiction":"us","citation":"21 CFR 888.3060","heading":"Spinal intervertebral body fixation orthosis.","body":"(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.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 888—ORTHOPEDIC DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"12c1c5aa2f43f34b66896b9a34efbc045077c9fe8756c490ca996bacf2387b3c","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-888.3050","next":"us/21-cfr-888.3070"},"notice":"GroundRules: Original legal text. Not legal advice."}