21 C.F.R. § 888.3020
Intramedullary fixation rod.
Cite as 21 C.F.R. § 888.3020 (2026)
(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.