21 C.F.R. § 874.3450 Partial ossicular replacement prosthesis.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices
§ 874.3450 Partial ossicular replacement prosthesis.
