21 CFR 874.3450 — Prosthesis, Partial Ossicular Replacement

Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3450

Identification

A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.

Classification Rationale

Class II.

Product Codes