Device Type ID | 1323 |
Device Name | Glenoid Fossa Prosthesis |
Regulation Description | Glenoid Fossa Prosthesis. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | PMA |
CFR Regulation Number | 872.3950 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | MPI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1323 |
Device | Glenoid Fossa Prosthesis |
Product Code | MPI |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Glenoid Fossa Prosthesis. |
CFR Regulation Number | 872.3950 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
Component Missing | 1 |
Total Device Problems | 2 |