Definition: Call For Pmas To Be Filed By 12/26/96 Per 61 Fr 50711 On 9/27/96
| Device Type ID | 4589 |
| Device Name | Metallic Cemented Glenoid Hemi-shoulder Prosthesis |
| Regulation Description | Shoulder Joint Glenoid (hemi-shoulder) Metallic 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 | 888.3680 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KYM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4589 |
| Device | Metallic Cemented Glenoid Hemi-shoulder Prosthesis |
| Product Code | KYM |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Shoulder Joint Glenoid (hemi-shoulder) Metallic Cemented Prosthesis. |
| CFR Regulation Number | 888.3680 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |