Definition: Pma To Be Filed By 1/3/05 (69 Fr 59134 (10/4/04)) For Any Hip Joint Metal/polymer Or Ceramic/polymer Semiconstrained Resurfacing Cemented Prosthesis That Was In Commercial Distribution Before May 28, 1976, Or That Has, On Or Before January 3, 2005, B
| Device Type ID | 4582 |
| Device Name | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/polymer |
| Regulation Description | Hip Joint Metal/polymer Or Ceramic/polymer Semiconstrained Resurfacing Cemented 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 | 888.3410 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KXB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4582 |
| Device | Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/polymer |
| Product Code | KXB |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Hip Joint Metal/polymer Or Ceramic/polymer Semiconstrained Resurfacing Cemented Prosthesis. |
| CFR Regulation Number | 888.3410 [🔎] |