Humelock Reversed Shoulder
FDA UDIEUDAMEDClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock Reversed Shoulder FDA UDI
- Generic Name
- Stem-fixed metallic humeral head prosthesis FDA UDI
- Device Name
- OFFSET HEAD CoCr 52x21 EUDAMEDOFFSET HEAD CrCo 52x21 FDA UDI
- Model / Reference
- 106-5200 EUDAMEDFDA UDI
- Description
- OFFSET HEAD CrCo 52x21 FDA UDI
Identifiers
- Catalog Number
- 106-5200 FDA UDI
- Primary DI / UDI-DI
- 03701037303764 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037303764 EUDAMED
- 510(k) Number
- K162455 FDA UDI
- FDA Product Code
- HSD FDA UDI
- EMDN Code
- P090104010101 EPIPHYSARY HUMERAL COMPONENTS FOR ANATOMICAL PROSTHESES - HUMERAL HEADS EUDAMED
- GMDN Term
- Stem-fixed metallic humeral head prosthesis FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3690 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Stem-fixed metallic humeral head prosthesis
Humelock Reversed Shoulder by Fx Solutions — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stem-fixed metallic humeral head prosthesis.
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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 (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fx Solutions
Sources (2)
- FDA UDI d93e9f69-803b-4f9c-88d1-4a3c193c9181 35 fields · synced Jul 8, 2026
- EUDAMED 45a62315-c589-4bd9-a047-d91233e16e31 61 fields · synced Jul 8, 2026