FDA applicant
Innosys Co., Ltd.
FDA records 5 decisions for Innosys Co., Ltd. (Uijeongbu-Si, KR) from 2023 to 2024: 5 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and HSB (Rod, Fixation, Intramedullary And Accessories). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 72 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Innosys”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Innosys Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Innosys Co., 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