21 CFR 888.3690
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 888.3690, § 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91122
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.