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21 C.F.R. § 888.3170   Elbow joint radial (hemi-elbow) polymer prosthesis.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 888—ORTHOPEDIC DEVICES
Subpart D—Prosthetic Devices

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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.

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