| Device Type ID | 1594 |
| Device Name | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene |
| 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 | LBN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1594 |
| Device | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene |
| Product Code | LBN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Total Ossicular Replacement Prosthesis. |
| CFR Regulation Number | 874.3495 [🔎] |