ALPHA SPINAL SYSTEM
Device Facts
| Record ID | K930515 |
|---|---|
| Device Name | ALPHA SPINAL SYSTEM |
| Applicant | Alphatec Mfg., Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Jun 29, 1994 |
| Decision | SESK |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
