← Back to catalogue
Humelock II Cementless Shoulder System
FDA UDIClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock II Cementless Shoulder System FDA UDI
- Generic Name
- Shoulder prosthesis screw FDA UDI
- Device Name
- CORTICAL SCREW TA6V Ø4.5mm L.38mm FDA UDI
- Model / Reference
- 107-4538 FDA UDI
- Description
- CORTICAL SCREW TA6V Ø4.5mm L.38mm FDA UDI
Identifiers
- Catalog Number
- 107-4538 FDA UDI
- Primary DI / UDI-DI
- 03701037302934 FDA UDI
- 510(k) Number
- K130759 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Shoulder prosthesis screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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 — 38 Millimeter FDA UDI
Category: Shoulder prosthesis screw
Humelock II Cementless Shoulder System by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder prosthesis screw.
- Comprehensive Reverse Shoulder — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE SRS — Biomet Orthopedics, Inc. · Class II
- COMPREHENSIVE REVERSE SHOULDER — Biomet Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- Titan™ — Ascension Orthopedics, Inc. · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- Titan™ — Ascension Orthopedics, Inc. · 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 (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 b7d66426-f623-48b6-92a3-45d0743673ab 37 fields · synced May 31, 2026