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Tibial Infrapatellar Insertion Handle
EUDAMEDFDA UDIClass I (EU MDR)
Ref INS-1109
by OrthoXel DAC
Identity
- Trade Name
- Tibial Infrapatellar Insertion Handle EUDAMEDApex FDA UDI
- Generic Name
- Orthopaedic implant aiming arm FDA UDI
- Device Name
- Tibial Infrapatellar Insertion Handle EUDAMEDFDA UDI
- Model / Reference
- INS-1109 EUDAMEDFDA UDI
- Description
- Tibial Infrapatellar Insertion Handle FDA UDI
Identifiers
- Catalog Number
- INS-1109 FDA UDI
- Primary DI / UDI-DI
- 05391529584061 EUDAMEDFDA UDI
- Basic UDI-DI
- 53915295840616F EUDAMEDB-05391529584061 EUDAMED
- Direct Marketing DI
- 05391529584061 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 implant aiming arm 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
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
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 Infrapatellar Insertion Handle by OrthoXel DAC — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 53915295840616F | Class I | Active |
| EUDAMED | European Union | CE/MDR | 53915295840616F | 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 (3)
- EUDAMED 5c93858c-d263-4639-b289-931d9d6d3caa 61 fields · synced Jul 22, 2026
- EUDAMED 7d76dd4e-6337-4c9a-87aa-6641f82817f9 61 fields · synced May 18, 2026
- FDA UDI b4fcc581-13a5-448a-ac69-40e7a9388194 37 fields · synced May 30, 2026