Definition: Call For PMAs 12/26/96 (61 FR 50709 (9/27/96))
| Device Type ID | 4584 |
| Device Name | Prosthesis, Hip, Constrained, Metal |
| Regulation Description | Hip Joint Metal Constrained Cemented Or Uncemented Prosthesis. |
| Regulation Medical Specialty | Orthopedic |
| 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 |
| CFR Regulation Number | 888.3300 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KXD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4584 |
| Device | Prosthesis, Hip, Constrained, Metal |
| Product Code | KXD |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint Metal Constrained Cemented Or Uncemented Prosthesis. |
| CFR Regulation Number | 888.3300 [🔎] |
| Device Problems | |
|---|---|
Material Integrity Problem | 2 |
| Total Device Problems | 2 |