FDA applicant
Inion, Ltd.
FDA records 37 decisions for Inion, Ltd. (Tampere, FI) from 2001 to 2025: 37 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and JEY (Plate, Bone). Its devices cite 82 predicates, 34 of them its own earlier devices. 4 recalls are linked to its devices.
FDA’s records also spell it “Inion OY”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Inion, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Inion, 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