21 CFR § 888.3690
Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis
June 25, 2020
(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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