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Humeris Shoulder
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K163669
by Fx Solutions
Identity
- Trade Name
- Humeris Shoulder FDA UDI
- Generic Name
- Coated shoulder humeral stem prosthesis FDA UDI
- Device Name
- HUMERIS STEM TA6V SIZE 20 CEMENTLESS Ti/HA FDA UDI
- Model / Reference
- 316-0020 FDA UDI
- Description
- HUMERIS STEM TA6V SIZE 20 CEMENTLESS Ti/HA FDA UDI
Identifiers
- Catalog Number
- 316-0020 FDA UDI
- Primary DI / UDI-DI
- 03701037304600 FDA UDI
- 510(k) Number
- FDA Product Code
- PHX FDA 510(k)FDA UDIHSD FDA UDI
- GMDN Term
- Coated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 888.3660 FDA 510(k)
- Regulation Number
- 888.3660 FDA 510(k)FDA UDI888.3690 FDA UDI
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Humeris Shoulder by Fx Solutions — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163669 | Class II | Active |
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Manufacturer
- Manufacturer
- Fx Solutions
Sources (2)
- FDA 510(k) K163669 24 fields · synced Jun 18, 2026
- FDA UDI 7a327bf0-b0c8-433b-b5b0-32761ea83dc9 37 fields · synced May 27, 2026