FDA applicant
Icotec AG
FDA records 17 decisions for Icotec AG (9450 Altstaetten (Sg), CH) from 2011 to 2025: 17 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and PML (Bone Cement, Posterior Screw Augmentation). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 87 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 17 of them its own earlier devices. 3 recalls are linked to its devices.
FDA’s records also spell it “Icotec”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Icotec AG’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Icotec AG’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