HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
Device Facts
| Record ID | K010378 |
|---|---|
| Device Name | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ |
| Applicant | Implex Corp. |
| Product Code | MQP · Orthopedic |
| Decision Date | Jan 28, 2002 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3060 |
| Device Class | Class 2 |
Regulatory Classification
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.
