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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 888 - Orthopedic Devices |
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Subpart D - Prosthetic Devices |
§ 888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis.
Latest version.
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§ 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.