Identity
- Trade Name
- NEOFUSE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- NEOFUSE LOCKING SCREW EUDAMEDLOCKING SCREW Ø4.5MM & CAP TITANIUM STERILE LG 48MM FDA UDI
- Model / Reference
- V45 ST548 EUDAMEDFDA UDI
- Description
- LOCKING SCREW Ø4.5MM & CAP TITANIUM STERILE LG 48MM FDA UDI
Identifiers
- Catalog Number
- V45 ST548 FDA UDI
- Primary DI / UDI-DI
- 03760225716823 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225716823 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 — 48 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-03760225716823 | 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 40e970b5-49cb-4fe5-864d-2856d18e3163 61 fields · synced Jun 19, 2026
- FDA UDI 67ccb500-d4ea-4f3e-8201-ee79adbba191 38 fields · synced May 30, 2026
- EUDAMED 1e3ac2aa-b333-46de-be11-e9eabdb0b1a1 61 fields · synced Jun 19, 2026