OJM · Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
Orthopedic · 21 CFR 888.3060 · Class 2
Overview
| Product Code | OJM |
|---|---|
| Device Name | Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
