21 CFR 888.3060 — Implant, Fixation Device, Spinal
Orthopedic (OR) · Part 888 Subpart D—Prosthetic Devices · § 888.3060
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JDN | Implant, Fixation Device, Spinal | 2 | 6 | Implant |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 663 | Implant |
| MQP | Spinal Vertebral Body Replacement Device | 2 | 277 | Implant |
| OJB | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate | 2 | 3 | Implant |
| OJM | Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh | 2 | 0 | Implant |
| PHQ | Anterior Staple As Supplemental Fixation For Fusion | 2 | 2 | Implant |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | 2 | 18 | Implant |
