Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis
- US Product Code (FDA)
- QKWView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 888.3695View CFR Regulation →
- Medical specialty
- Orthopedic
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
A shoulder joint humeral (hemi-shoulder) ceramic head / metallic stem cemented or uncemented prosthesis is a device using a replacement humeral head made of ceramic materials, such as pyrolytic carbon,and a stem made of alloys, such as cobalt-chromium-molybdenum. It is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed with or without bone cement (§ 888.3027). This device is not intended for use in total shoulder arthroplasty.
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Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.