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Apex Tibial Nailing System Case
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref INS-1131510(k) K170972Model INS-1079
by OrthoXel DAC
Identity
- Trade Name
- Apex Tibial Nailing System Case EUDAMEDApex FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Apex Tibial Nailing System Case EUDAMEDFDA UDIApex Nailing System Opening and Reaming Case EUDAMED
- Model / Reference
- INS-1131 EUDAMEDFDA UDIINS-1079 EUDAMED
- Description
- Apex Tibial Nailing System Case FDA UDI
Identifiers
- Catalog Number
- INS-1131 FDA UDI
- Primary DI / UDI-DI
- 05391529585150 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391529585150 EUDAMED53915295822035V EUDAMED
- Direct Marketing DI
- 05391529585150 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
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
Apex Tibial Nailing System Case by OrthoXel DAC — Class I — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Manufacturer's product page: Apex Tibial Nailing System
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170972 | Class I | Active |
| EUDAMED | European Union | CE/MDR | B-05391529585150 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-05391529585150 | Class I | Active |
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Manufacturer
- Manufacturer
- OrthoXel DAC
- EUDAMED SRN
- IE-MF-000000574
- FDA Applicant
- Orthoxel
Sources (4)
- EUDAMED 0ee32ceb-7cc0-4c9d-a07c-8be528fc25f4 85 fields · synced Jul 14, 2026
- EUDAMED 728aab2a-66f0-4da1-97cd-3488f28c6ec3 61 fields · synced May 17, 2026
- FDA UDI f071d635-5f5a-4b10-be28-bc3c6a494e02 36 fields · synced May 30, 2026
- FDA 510(k) K170972 1 fields · synced May 18, 2026