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§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

21 CFR 888.3170

Citation21 CFR 888.3170
CorpusDaily eCFR
Displayed edition2026-05-18
Last updated2026-05-18

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(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.