21 CFR § 888.3020
Intramedullary fixation rod
June 25, 2020
(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.