21 CFR § 874.3450 Ear, Nose, and Throat Devices

§ 874.3450 Partial ossicular replacement prosthesis.

Current through Sep 8, 2026 · Read all of Part 874

(a) 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.

(b) Classification. Class II.

← § 874.3430 Middle ear mold.§ 874.3495 Total ossicular replacement prosthesis. →