21 CFR 874.3495 — Replacement, Ossicular Prosthesis, Total
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3495
Identification
A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 39 | Implant |
| LBN | Replacement, Total Ossicular, Prosthesis, Porous, Polyethylene | 2 | 1 | Implant |
