Humelock II Cemented Shoulder System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock II Cemented Shoulder System FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- 2 PEGS GLENOID PE CEMENTED SIZE XS EUDAMEDFDA UDI
- Model / Reference
- 105-0001 EUDAMEDFDA UDI
- Description
- 2 PEGS GLENOID PE CEMENTED SIZE XS FDA UDI
Identifiers
- Catalog Number
- 105-0001 FDA UDI
- Primary DI / UDI-DI
- 03701037300169 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037300169 EUDAMED
- 510(k) Number
- K123814 FDA UDI
- FDA Product Code
- KWT FDA UDI
- EMDN Code
- P09010303 GLENOSPHERES EUDAMED
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3650 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Height — 27 Millimeter FDA UDI
Category: Shoulder glenoid fossa prosthesis, prefabricated
Humelock II Cemented Shoulder System by Fx Solutions — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
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- AEQUALIS™ PerFORM — TORNIER, INC. · Class II
Cleared under the same submission
K123814 also covers:
- FX Solutions — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
- Humelock II Cemented Shoulder System — FX SOLUTIONS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fx Solutions
Sources (2)
- FDA UDI 62bd2668-5588-4c33-a402-d8c1dbd97fc8 38 fields · synced Jun 14, 2026
- EUDAMED b15ca463-bba5-4f86-88a5-7a91b098fc0a 61 fields · synced Jun 14, 2026