| Device Type ID | 1455 |
| Device Name | Prosthesis, Partial Ossicular Replacement |
| Regulation Description | Partial 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 | 874.3450 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ETB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1455 |
| Device | Prosthesis, Partial Ossicular Replacement |
| Product Code | ETB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Partial Ossicular Replacement Prosthesis. |
| CFR Regulation Number | 874.3450 [🔎] |
| Device Problems | |
|---|---|
Break | 4 |
Detachment Of Device Or Device Component | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Difficult Or Delayed Positioning | 1 |
| Total Device Problems | 8 |