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Humelock II Cemented Reversible Shoulder
FDA UDIClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock II Cemented Reversible Shoulder FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- LOCKING SCREW TA6V Ø4.5mm L.42 mm FDA UDI
- Model / Reference
- 108-4542 FDA UDI
- Description
- LOCKING SCREW TA6V Ø4.5mm L.42 mm FDA UDI
Identifiers
- Catalog Number
- 108-4542 FDA UDI
- Primary DI / UDI-DI
- 03701037302446 FDA UDI
- 510(k) Number
- K150488 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 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
- Length — 42 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Humelock II Cemented Reversible Shoulder by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — 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
K150488 also covers:
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible Shoulder — FX SOLUTIONS
- Humelock II Cemented Reversible 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 2dbde178-a47b-4c8b-a85c-35c7044f77da 38 fields · synced May 31, 2026