Title 21: Food and Drugs
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/ PART 888 - ORTHOPEDIC DEVICES
/ Subpart D - Prosthetic Devices / § 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
§ 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.