Elbow joint radial (hemi-elbow) polymer prosthesis.

21 C.F.R. § 888.3170

in effectEffective: 2024-07-01

(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.

Source: eCFRURL: https://www.ecfr.gov/api/versioner/v1/full/2024-07-01/title-21.xmlFetched: 7/26/2026