21 C.F.R. § 888.3060
Spinal intervertebral body fixation orthosis.
Cite as 21 C.F.R. § 888.3060 (2026)
(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.