eCFR Reference Browser

---

title: "21 CFR §874.3450"

source: "https://www.ecfr.gov/current/title-21/section-874.3450"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "874"

part_subject: "EAR, NOSE, AND THROAT DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "874.3450"

section_subject: "Partial ossicular replacement prosthesis."

cfr_reference: "21 CFR 874.3450"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§874.3450 - Partial ossicular replacement prosthesis.