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CFR

888.3690—Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.

(a) Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement ( § 888.3027 ). This device is not intended for biological fixation.
(b) Classification. Class II.
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