← Back to catalogue
Humelock Reversed System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 105-3210
by Fx Solutions
Identity
- Trade Name
- Humelock Reversed System FDA UDI
- Generic Name
- Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
- Device Name
- HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm EUDAMEDFDA UDI
- Model / Reference
- 105-3210 EUDAMEDFDA UDI
- Description
- HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø32mm FDA UDI
Identifiers
- Catalog Number
- 105-3210 FDA UDI
- Primary DI / UDI-DI
- 03701037309476 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701037309476 EUDAMED
- 510(k) Number
- K192206 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 32 Millimeter FDA UDI
Category: Shoulder glenoid fossa prosthesis, prefabricated
Humelock Reversed System 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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 35bc3d1d-fece-4c19-9ff9-c637dd4a0d25 37 fields · synced Jun 14, 2026
- EUDAMED c343ba17-ef30-44cb-ae02-3dfacaf1d44e 61 fields · synced Jun 14, 2026