Identity
- Trade Name
- NEOFUSE EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- NEOFUSE® Arthrodesis PLATING SYSTEM EUDAMEDDRILL DIAM 3.2 MM LG200 MM HIND FOOT PLATE FDA UDI
- Model / Reference
- P02 00131 EUDAMEDFDA UDI
- Description
- DRILL DIAM 3.2 MM LG200 MM HIND FOOT PLATE FDA UDI
Identifiers
- Catalog Number
- P02 00131 FDA UDI
- Primary DI / UDI-DI
- 03760225717059 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760225717059 EUDAMED
- 510(k) Number
- K173121 FDA UDI
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Wire holding/twisting forceps
Neofuse by In2Bones SAS — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wire holding/twisting forceps.
- WAVY FRENCH BENDER — ETABLISSEMENTS OURY GUYE ET FILS · Class I
- CANULA TAP 4.5 FOR SCREW 6.5 — groupe lépine · Class I
- ROCCIA MultiLIF, ALIF, TLIF — SILONY MEDICAL GMBH · Class I
- Raszpla — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Preparator — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Retraktor — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Trokar — ChM spółka z ograniczoną odpowiedzialnością · Class I
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class I
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-03760225717059 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- In2Bones SAS
- EUDAMED SRN
- FR-MF-000005246
Sources (2)
- EUDAMED c7b5fb96-daba-4ce6-9cd3-1e25ea7312ca 61 fields · synced Jun 17, 2026
- FDA UDI 2acf6276-8667-4090-a2c2-94b44602a727 36 fields · synced May 30, 2026