21 C.F.R. § 874.3450

Partial ossicular replacement prosthesis.

Last amended: 2016Year: 2026Length: 73 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 874.3450 (2026)

(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.
21 C.F.R. § 874.3450: Partial ossicular replacement prosthesis. | Justis AI