| Device Type ID | 4720 |
| Device Name | Spinal Pedicle Screw, Fixation, Appliance System |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MCV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4720 |
| Device | Spinal Pedicle Screw, Fixation, Appliance System |
| Product Code | MCV |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Break | 2 |
Mechanical Problem | 1 |
Noise, Audible | 1 |
Migration | 1 |
Failure To Osseointegrate | 1 |
Unintended Ejection | 1 |
| Total Device Problems | 7 |