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Apex Tibial Nail Ø 10 x 375mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T02-100375
by OrthoXel DAC
Identity
- Trade Name
- Apex Tibial Nail Ø 10 x 375mm EUDAMEDApex FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- Apex Tibial Nail Ø 10 x 375mm EUDAMEDFDA UDI
- Model / Reference
- T02-100375 EUDAMEDFDA UDI
- Description
- Apex Tibial Nail Ø 10 x 375mm FDA UDI
Identifiers
- Catalog Number
- T02-100375 FDA UDI
- Primary DI / UDI-DI
- 05391529584573 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529584573 EUDAMED
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- GMDN Term
- Tibia intramedullary nail FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Ireland 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
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
Apex Tibial Nail Ø 10 x 375mm by OrthoXel DAC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Apex Tibial Nailing System
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-05391529584573 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 9e661b19-b720-45b5-9d89-7844b9eb1ff7 61 fields · synced Jun 18, 2026
- FDA UDI 904dec04-458a-4141-899e-a5ea214c1d25 38 fields · synced May 30, 2026