FDA applicant
Eventum Orthopaedics, Ltd.
FDA records 2 decisions for Eventum Orthopaedics, Ltd. (Leeds, GB) from 2024 to 2025: 2 510(k) clearances. All are in product code ONN (Intraoperative Orthopedic Joint Assessment Aid). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Eventum Orthopaedics, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Eventum Orthopaedics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report