Code of Federal Regulations · Section

§ 888.3170 — Elbow Joint Radial (hemi-elbow) Polymer Prosthesis

21 C.F.R. § 888.3170

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(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.

21 C.F.R. § 888.3160 21 C.F.R. § 888.3180

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