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21 C.F.R. § 888.3170 – Elbow joint radial (hemi-elbow) polymer prosthesis. | Midpage
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Code of Federal Regulations
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Subchapter H
Part 888
Subpart D
§ 888.3170
21 C.F.R. § 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.