Data / Medical devices / United Kingdom / Axis Spine Technologies Ltd
Axis Spine Technologies Ltd: FDA-registered device maker in Leeds, United Kingdom, 1 510(k) clearance
Axis Spine Technologies Ltd is registered with the FDA (registration 3016668776) in Leeds, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016668776
- Address
- Century Offices 2175 Century Way, Thorpe Park, Leeds, United Kingdom, LS15 8ZB
- Owner or operator
- Axis Spine Technologies Ltd (10078787)
- Roles
- Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer
- First device listed
- December 22, 2021
- Registered through
- 2026
- Brand names listed
- AXIS ALIF IMPLANTS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 2 | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, 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 |
|---|---|---|---|---|---|---|
| September 29, 2021 | K210590 | Axis Spine Technologies ALIF | OVD | Substantially Equivalent | Axis Spine Technologies, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2021. 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.