| Device |
sacroiliac joint fixation |
| Regulation Description |
Smooth or threaded metallic bone fixation fastener. |
| Definition |
Sacroiliac joint fusion. |
| Physical State |
may be used with bone graft, should not be used with bone cement |
| Technical Method |
bridges both sides of the joint, preventing motion |
| Target Area |
sacroiliac joint |
| Regulation Medical Specialty |
Orthopedic |
| Review Panel |
Orthopedic |
|---|
| Product Code | OUR |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
888.3040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
