Definition: Call For Pmas 12/26/96 ( 61 Fr 50710 9/27/96)
| Device Type ID | 4550 |
| Device Name | Metal Cemented Constrained Femorotibial Knee Prosthesis |
| Regulation Description | Knee Joint Femorotibial Metallic Constrained 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 One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | PMA |
| CFR Regulation Number | 888.3480 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KRN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4550 |
| Device | Metal Cemented Constrained Femorotibial Knee Prosthesis |
| Product Code | KRN |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Knee Joint Femorotibial Metallic Constrained Cemented Prosthesis. |
| CFR Regulation Number | 888.3480 [🔎] |
| Device Problems | |
|---|---|
Tear, Rip Or Hole In Device Packaging | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 2 |