Apex Tibial/Retrograde Endcap 5mm
EUDAMEDFDA UDIClass IIb (EU MDR)
by OrthoXel DAC
Identity
- Trade Name
- Apex Tibial/Retrograde Endcap 5mm EUDAMEDApex FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Device Name
- Apex Tibial/Retrograde Endcap 5mm EUDAMEDApex Tibial Endcap 5mm Length FDA UDI
- Model / Reference
- E03-005 EUDAMEDFDA UDI
- Description
- Apex Tibial Endcap 5mm Length FDA UDI
Identifiers
- Catalog Number
- E03-005 FDA UDI
- Primary DI / UDI-DI
- 05391529585105 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529585105 EUDAMED
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120201 INTRAMEDULLARY NAILS EUDAMED
- GMDN Term
- Bone nail end-cap 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Arthrodesis intramedullary nail, non-distracting
Apex Tibial/Retrograde Endcap 5mm by OrthoXel DAC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Arthrodesis intramedullary nail, non-distracting.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529585105 | 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 1a4ed22c-3788-41c2-b5c2-c79f3fe84392 61 fields · synced Jul 12, 2026
- FDA UDI e6b5446b-3643-4c61-9fbd-7cfabb64be05 38 fields · synced May 30, 2026