Identity
- Trade Name
- NEOFUSE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- NEOFUSE TRANSFOCAL SCREW EUDAMEDTRANSFOCAL SCREW 4.5MM TITANIUM STERILE LG 46MM FDA UDI
- Model / Reference
- V45 ST146 EUDAMEDFDA UDI
- Description
- TRANSFOCAL SCREW 4.5MM TITANIUM STERILE LG 46MM FDA UDI
Identifiers
- Catalog Number
- V45 ST146 FDA UDI
- Primary DI / UDI-DI
- 03760225716878 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225716878 EUDAMED
- 510(k) Number
- K173121 FDA UDI
- FDA Product Code
- HWC FDA UDI
- EMDN Code
- P09120503 OSTEOSYNTHESIS SCREW-PLATE SYSTEMS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- Not 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 46 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDI
Neofuse by In2Bones SAS — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760225716878 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (3)
- EUDAMED eccb39a3-12b0-4e71-8362-4ae446dce201 61 fields · synced Jun 18, 2026
- FDA UDI 6d01a7d3-86ae-4e8d-b64f-57a0413963f5 38 fields · synced May 30, 2026
- EUDAMED dee170e4-366f-4c66-a8c9-56e3fcdc8228 61 fields · synced Jun 18, 2026