Identity
- Trade Name
- Humelock Reversed Shoulder FDA UDI
- Generic Name
- Uncoated shoulder humeral stem prosthesis FDA UDI
- Device Name
- HUMELOCK REVERSED STEM TA6V CEMENTED Ø36/10 FDA UDI
- Model / Reference
- 313-3610 FDA UDI
- Description
- HUMELOCK REVERSED STEM TA6V CEMENTED Ø36/10 FDA UDI
Identifiers
- Catalog Number
- 313-3610 FDA UDI
- Primary DI / UDI-DI
- 03701037301425 FDA UDI
- 510(k) Number
- K162455 FDA UDI
- FDA Product Code
- PHX FDA UDIHSD FDA UDI
- GMDN Term
- Uncoated shoulder humeral stem prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3690 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
Yes
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
Category: Uncoated shoulder humeral stem prosthesis
Humelock Reversed Shoulder by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated shoulder humeral stem prosthesis.
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Bigliani/Flatow® — Zimmer, Inc. · Class II
- REUNION — Stryker Corp. · Class II
- REUNION — Stryker Corp. · Class II
- LINK Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- Anatomical Shoulder™ — Zimmer, Inc. · Class II
- Embrace Shoulder System — WALDEMAR LINK GmbH & Co. KG · Class II
- SMR System — Limacorporate · Class II
Cleared under the same submission
K162455 also covers:
- HUMELOCK REVERSED — FX SOLUTIONS
- HUMELOCK REVERSED — FX SOLUTIONS
- Humelock Reversed — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed Shoulder — FX SOLUTIONS
- Humelock Reversed 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 |
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Manufacturer
- Manufacturer
- Fx Solutions
Sources (1)
- FDA UDI 9fcee08a-ba27-4e0f-aa1b-3b8e35f5005e 36 fields · synced May 30, 2026