| Device Type ID | 1454 |
| Device Name | Replacement, Ossicular Prosthesis, Total |
| Regulation Description | Total Ossicular Replacement Prosthesis. |
| Regulation Medical Specialty | Ear Nose & Throat |
| Review Panel | Ear Nose & Throat |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Ear, Nose, And Throat Devices Branch (ENTB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 874.3495 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ETA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1454 |
| Device | Replacement, Ossicular Prosthesis, Total |
| Product Code | ETA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Ossicular Replacement Prosthesis. |
| CFR Regulation Number | 874.3495 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 6 |
Extrusion | 5 |
Material Fragmentation | 4 |
Break | 3 |
Unexpected Therapeutic Results | 3 |
Fracture | 1 |
Device Dislodged Or Dislocated | 1 |
Device Remains Implanted | 1 |
| Total Device Problems | 24 |