21 CFR 888.3060
§ 888.3060 Spinal intervertebral body fixation orthosis.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 888.3060, § 888.3060 Spinal intervertebral body fixation orthosis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91068
- Permanent ID
ys:prov:91068@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.