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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
- Humeral head spacer FDA UDI
- Device Name
- REVERSED ADAPTER TA6V 135/145° FDA UDI
- Model / Reference
- 112-0100 FDA UDI
- Description
- REVERSED ADAPTER TA6V 135/145° FDA UDI
Identifiers
- Catalog Number
- 112-0100 FDA UDI
- Primary DI / UDI-DI
- 03701037300770 FDA UDI
- 510(k) Number
- K150488 FDA UDI
- FDA Product Code
- PHX FDA UDI
- GMDN Term
- Humeral head spacer 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
- Angle — 10 degree FDA UDI
Category: Humeral head spacer
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 Humeral head spacer.
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- SMR System — Limacorporate · Class II
- SMR System — Limacorporate · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · Class II
- Aequalis™ Adjustable Reversed — TORNIER, INC. · 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 9e15ac56-2fa3-46ae-921f-7c364f9e114e 38 fields · synced May 30, 2026