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Code of Federal Regulations Title 21. Food and Drugs § 21.888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis

Current as of January 02, 2025 | Updated by Findlaw Staff

(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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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-888-3690/

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