21 CFR 888.3020 - Intramedullary fixation rod.

Regulations last checked for updates: May 02, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart D [§ 888.3000 - § 888.3810]

§ 888.3020 - Intramedullary fixation rod.

(a) Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33702, Sept. 4, 1987, unless otherwise noted.

cite as: 21 CFR 888.3020