Data / Medical devices / Ireland / Orthoxel
Orthoxel: FDA-registered device maker in Cork Cork(City), Ireland, 3 510(k) clearances
Orthoxel is registered with the FDA (registration 3014976005) in Cork Cork(City), Ireland. It lists 11 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014976005
- Address
- Cube House, Cork Business and Technology Park, Model Farm Road Bishopstown, Cork Cork(City), Ireland, T12 H966
- Owner or operator
- OrthoXel (10058878)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 21, 2018
- Registered through
- 2026
- Brand names listed
- Apex Femoral Nailing System, Apex Nailing System Instrumentation, Apex Tibial Nailing System, Apex Tibial Nailing System Instrumentation, Apex Tibial Nailing System Instrumention, Vertex Hip Fracture Nailing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Awl | HWJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Nail, Fixation, Bone | JDS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Wrench | HXC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 4, 2024 | K233910 | Vertex Hip Fracture Nailing System | HSB | Substantially Equivalent | Orthoxel Dac | accessdata.fda.gov |
| July 17, 2018 | K181375 | Apex Femoral Nailing System | HSB | Substantially Equivalent | Orthoxel | accessdata.fda.gov |
| December 20, 2017 | K170972 | Apex Tibial Nailing System | HSB | Substantially Equivalent | Orthoxel | accessdata.fda.gov |
Compare with other makers
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Wrench
- All makers of Screwdriver
- All makers of Reamer
- All makers of Screw, Fixation, Bone
- All makers of Gauge, Depth
Updated April 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.