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Apex Tibial Nail Ø 9.0 x 330mm
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref T02-900330
by OrthoXel DAC
Identity
- Trade Name
- Apex Tibial Nail Ø 9.0 x 330mm EUDAMEDApex FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- Apex Tibial Nail Ø 9.0 x 330mm EUDAMEDFDA UDI
- Model / Reference
- T02-900330 EUDAMEDFDA UDI
- Description
- Apex Tibial Nail Ø 9.0 x 330mm FDA UDI
Identifiers
- Catalog Number
- T02-900330 FDA UDI
- Primary DI / UDI-DI
- 05391529584429 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529584429 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 9.0 x 330mm 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-05391529584429 | 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 f8108d5f-2a42-448f-8ee8-d9f0eaa64c3f 61 fields · synced Aug 1, 2026
- FDA UDI a48baa39-f781-46c9-a270-4eb9e8c907bf 38 fields · synced May 30, 2026