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Tibial Nail Extraction Bolt
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1004
by OrthoXel DAC
Identity
- Trade Name
- Tibial Nail Extraction Bolt EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- Tibial Nail Extraction Bolt EUDAMEDTibial Extraction Bolt FDA UDI
- Model / Reference
- INS-1004 EUDAMEDFDA UDI
- Description
- Tibial Extraction Bolt FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391529582180 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529582180 EUDAMED
- 510(k) Number
- K170972 FDA UDI
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Moist Heat or Steam Sterilization FDA UDI
Tibial Nail Extraction Bolt by OrthoXel DAC — Class I — 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-05391529582180 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
Sources (2)
- EUDAMED e1825563-72a1-4008-8698-98f8df4fc15a 61 fields · synced Jul 24, 2026
- FDA UDI e03ef6cb-c86f-45c0-a43b-b87d1f5b7d18 36 fields · synced May 30, 2026