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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
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- OFFSET HEAD CrCo 41x16 FDA UDI
- Model / Reference
- 106-4100 FDA UDI
- Description
- OFFSET HEAD CrCo 41x16 FDA UDI
Identifiers
- Catalog Number
- 106-4100 FDA UDI
- Primary DI / UDI-DI
- 03701037300473 FDA UDI
- 510(k) Number
- K123814 FDA UDI
- FDA Product Code
- HSD FDA UDI
- GMDN Term
- Stem-fixed metallic humeral head prosthesis 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
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
- Outer Diameter — 41 Millimeter FDA UDI
Category: Stem-fixed metallic humeral head prosthesis
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 Stem-fixed metallic humeral head prosthesis.
- MRS — Howmedica Osteonics Corp. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
- FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
- PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
- Equinoxe — Exactech, Inc. · Class II
- TORNIER PERFORM™ HUMERAL SYSTEM — 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 2c660583-162e-4d0b-8a68-3b018e1b33ee 38 fields · synced May 30, 2026