LYP · Accessories, Fixation, Spinal Interlaminal
Orthopedic · 21 CFR 888.3050 · Class 2
Overview
| Product Code | LYP |
|---|---|
| Device Name | Accessories, Fixation, Spinal Interlaminal |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
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.
Classification Rationale
Class II.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890185 | C-S IMPACTOR | Orthopedic Systems, Inc. | Apr 6, 1989 | SESE |
Top Applicants
- Orthopedic Systems, Inc. — 1 clearance
