Last amended:2016Year:2026Length:35 wordsSubsections:2Official source
Cite as 21 C.F.R. § 888.3170 (2026)
(a)
Identification.
An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.
(b)
Classification.
Class II.