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§ 874.3450 Partial ossicular replacement prosthesis.

21 CFR 874.3450

Citation21 CFR 874.3450
CorpusDaily eCFR
Displayed edition2026-04-27
Last updated2026-04-27

§ 874.3450 Partial ossicular replacement prosthesis.

(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.