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§ 888.3060 Spinal intervertebral body fixation orthosis.

21 CFR 888.3060

Citation21 CFR 888.3060
CorpusDaily eCFR
Displayed edition2026-10-01
Last updated2026-10-01

§ 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.

Authority21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Source52 FR 33702, Sept. 4, 1987, unless otherwise noted.