Apex Antegrade Femoral Endcap 5mm Length
EUDAMEDFDA UDIClass IIb (EU MDR)
by OrthoXel DAC
Identity
- Trade Name
- Apex Antegrade Femoral Endcap 5mm Length EUDAMEDApex FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Device Name
- Apex Antegrade Femoral Endcap 5mm Length EUDAMEDFDA UDI
- Model / Reference
- E02-005 EUDAMEDFDA UDI
- Description
- Apex Antegrade Femoral Endcap 5mm Length FDA UDI
Identifiers
- Catalog Number
- E02-005 FDA UDI
- Primary DI / UDI-DI
- 05391529582135 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582135 EUDAMED
- 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
Yes
Category: Arthrodesis intramedullary nail, non-distracting
Apex Antegrade Femoral Endcap 5mm Length by OrthoXel DAC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
Manufacturer's product page: Apex Femoral Antegrade Nailing System
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391529582135 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED 76dba754-9724-42db-8753-8fa3cfbaf006 61 fields · synced Jul 28, 2026
- FDA UDI 5c97850e-1e8f-4961-8b2c-d020cf75dc7d 37 fields · synced May 30, 2026