Data / Medical devices / Ireland / X-Bolt Orthopedics
X-Bolt Orthopedics: FDA-registered device maker in Santry Dublin(County), Ireland, 2 510(k) clearances
X-Bolt Orthopedics is registered with the FDA (registration 3010368646) in Santry Dublin(County), Ireland. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 6, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010368646
- Address
- Unit 5 Northwood Court, Santry Dublin(County), Ireland, D09AX54
- Owner or operator
- X-Bolt Orthopedics (10085237)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- May 23, 2022
- Registered through
- 2026
- Brand names listed
- Pro-X1®, X-Bolt
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| March 6, 2023 | K221621 | Pro-X1 Trochanteric Nailing System | HSB | Substantially Equivalent | X-Bolt Orthopedics | accessdata.fda.gov |
| October 12, 2018 | K181640 | X-BOLT Hip Fracture Fixation System | HSB | Substantially Equivalent | X-Bolt Orthopaedics | accessdata.fda.gov |
Compare with other makers
- All makers of Rod, Fixation, Intramedullary And Accessories
- All makers of Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Updated March 6, 2023. 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.