Definition: Pma Approved: P000057
| Device Type ID | 4733 |
| Device Name | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NEG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4733 |
| Device | Finger Semi-constrained Pyrolytic Carbon Uncemented Prosthesis |
| Product Code | NEG |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Break | 13 |
Material Integrity Problem | 3 |
Device Operates Differently Than Expected | 3 |
Fracture | 2 |
Noise, Audible | 2 |
Detachment Of Device Component | 1 |
Fitting Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 26 |