Identity
- Trade Name
- Humeris Shoulder FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- 3-4 PEGS GLENOID PE CEMENTED SIZE M FDA UDI
- Model / Reference
- 400-1103 FDA UDI
- Description
- 3-4 PEGS GLENOID PE CEMENTED SIZE M FDA UDI
Identifiers
- Catalog Number
- 400-1103 FDA UDI
- Primary DI / UDI-DI
- 03701037301715 FDA UDI
- 510(k) Number
- K163669 FDA UDI
- FDA Product Code
- KWT FDA UDI
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3650 FDA UDI
- 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
Category: Shoulder glenoid fossa prosthesis, prefabricated
Humeris Shoulder by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K163669 also covers:
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
- Humeris Shoulder — FX SOLUTIONS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fx Solutions
Sources (1)
- FDA UDI 5687f5b5-7f08-45e3-a7e4-a80ee72bc806 37 fields · synced Jun 8, 2026