Humelock II Cementless Shoulder System
FDA UDIEUDAMEDClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock II Cementless Shoulder System FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- CORTICAL SCREW TA6V Ø4.5mm L.34mm EUDAMEDCORTICAL SCREW TA6V Ø4.5mm L.34mm FDA UDI
- Model / Reference
- 107-4534 EUDAMEDLength 34 mm FDA UDI
- Description
- CORTICAL SCREW TA6V Ø4.5mm L.34mm FDA UDI
Identifiers
- Catalog Number
- 107-4534 FDA UDI
- Primary DI / UDI-DI
- 03701037302002 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037302002 EUDAMED
- 510(k) Number
- K130759 FDA UDI
- FDA Product Code
- HSD FDA UDI
- EMDN Code
- P09018001 SHOULDER PROSTHESES FIXING SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3690 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
Category: Orthopaedic bone screw (non-sliding)
Humelock II Cementless Shoulder System by Fx Solutions — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Cleared under the same submission
K130759 also covers:
- FX Solutions — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless Shoulder System — FX SOLUTIONS
- Humelock II Cementless 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fx Solutions
Sources (2)
- FDA UDI cba3c255-4cf0-440e-b73b-e0df51d7aacb 37 fields · synced Jul 8, 2026
- EUDAMED 2c2b0454-81ba-4cc0-abc4-1e73f51ffcd6 61 fields · synced Jul 8, 2026