Humelock II Cemented Reversible Shoulder
FDA UDIEUDAMEDClass II (US FDA UDI)
by Fx Solutions
Identity
- Trade Name
- Humelock II Cemented Reversible Shoulder FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40mm EUDAMEDHUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40 mm FDA UDI
- Model / Reference
- 105-4011 EUDAMEDFDA UDI
- Description
- HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40 mm FDA UDI
Identifiers
- Catalog Number
- 105-4011 FDA UDI
- Primary DI / UDI-DI
- 03701037300312 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037300312 EUDAMED
- 510(k) Number
- K150488 FDA UDI
- FDA Product Code
- PHX FDA UDI
- EMDN Code
- P09010303 GLENOSPHERES EUDAMED
- GMDN Term
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3660 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
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 40 Millimeter FDA UDI
Category: Shoulder glenoid fossa prosthesis, prefabricated
Humelock II Cemented Reversible Shoulder by Fx Solutions — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Shoulder glenoid fossa prosthesis, prefabricated.
- PRIMA TT Glenoid — Limacorporate · Class II
- AEQUALIS REVERSED II — TORNIER, INC. · Class II
- INHANCE — DEPUY (IRELAND) · Class II
- TITAN™ — Ascension Orthopedics, Inc. · Class II
- Equinoxe — Exactech, Inc. · Class II
- SMR System — Limacorporate · Class II
- SMR Metal Back — Limacorporate · Class II
- AEQUALIS™ PerFORM — 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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fx Solutions
Sources (2)
- FDA UDI bc11a16c-87fc-41df-8284-76c3e74ee4c0 38 fields · synced Jul 8, 2026
- EUDAMED b72f7019-1dcf-4902-87dc-cc9dc6845765 61 fields · synced Jul 8, 2026