Data / Medical devices / United Kingdom / Eventum Orthopaedics Ltd
Eventum Orthopaedics Ltd: FDA-registered device maker in Leeds, United Kingdom, 1 510(k) clearance
Eventum Orthopaedics Ltd is registered with the FDA (registration 3033434191) in Leeds, United Kingdom. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033434191
- Address
- Richmond House Lawnswood Business Park, Redvers Cl, Leeds, United Kingdom, LS16 6QY
- Owner or operator
- Eventum Orthopaedics Ltd (10091583)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 17, 2024
- Registered through
- 2026
- Brand names listed
- Depth and Angle Adaptors, Extraction Tool, Quadsense, Reusable Shims
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intraoperative Orthopedic Joint Assessment Aid | ONN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| October 4, 2024 | K241298 | QUADSENSE | ONN | Substantially Equivalent | Eventum Orthopaedics, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Intraoperative Orthopedic Joint Assessment Aid
Updated October 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.