| Device |
patient specific manual orthopedic stereotaxic system |
| Regulation Description |
Stereotaxic instrument. |
| Definition |
Intended for defining orthopedic acetabular implant alignment relative to a patient's anatomy. |
| Physical State |
Manual instrument and auxiliary software. |
| Technical Method |
Pre-operative imagery, such as CT or radiographs, is used to establish a correlation between the patient's AP plane and the instrument¿s plane. |
| Target Area |
Acetabulum |
| Regulation Medical Specialty |
Neurology |
| Review Panel |
Orthopedic |
|---|
| Product Code | OSF |
|---|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4560
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
