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 |