Identity
- Trade Name
- In2Bones EUDAMEDFDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Ankle Fusion Sterile Instruments, Active EUDAMEDOlive Wire, Ø.062 x 2.4, 2-Pack, Single-Use, Sterile FDA UDI
- Model / Reference
- P02 S0131 EUDAMEDFDA UDI
- Description
- Olive Wire, Ø.062 x 2.4, 2-Pack, Single-Use, Sterile FDA UDI
Identifiers
- Catalog Number
- P02 S0131 FDA UDI
- Primary DI / UDI-DI
- 00810021865218 EUDAMEDFDA UDI
- Basic UDI-DI
- 08101755027042 EUDAMED
- 510(k) Number
- K213069 FDA UDI
- FDA Product Code
- HXI FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
In2Bones by In2Bones, USA — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08101755027042 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
- EUDAMED SRN
- US-MF-000023092
- Authorised Representative
- Conmed Europe BV BE-AR-000035662
Sources (2)
- EUDAMED d9a22536-1949-4e70-9c8b-219cbf10ab89 61 fields · synced Jun 8, 2026
- FDA UDI 9bb1050e-d21e-4b06-ba71-3f52539cd24a 36 fields · synced May 30, 2026