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Humelock II Cemented Shoulder System
FDA UDIClass 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
- Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE L FDA UDI
- Model / Reference
- 105-0004 FDA UDI
- Description
- Humelock II Cemented Shoulder System, 2 PEGS GLENOID PE CEMENTED SIZE L FDA UDI
Identifiers
- Catalog Number
- 105-0004 FDA UDI
- Primary DI / UDI-DI
- 03701037300190 FDA UDI
- 510(k) Number
- K123814 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 39 Millimeter FDA UDI
Category: Shoulder glenoid fossa prosthesis, prefabricated
Humelock II Cemented Shoulder System by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
- PRIMA TT Glenoid — Limacorporate · Class II
- AEQUALIS REVERSED II — TORNIER, INC. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- TITAN™ — Ascension Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- SMR System — Limacorporate · Class II
- SMR Metal Back — Limacorporate · Class II
- 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 (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 37fcd695-9642-4841-a661-410feab7af96 38 fields · synced May 30, 2026