FDA applicant
Innobiosurg Co., Ltd.
FDA records 15 decisions for Innobiosurg Co., Ltd. (Daejeon, KR) from 2015 to 2022: 15 510(k) clearances. Most are in product codes DZE (Implant, Endosseous, Root-Form) and NHA (Abutment, Implant, Dental, Endosseous). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 219 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 20 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 Innobiosurg Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2015.
Planning a device like Innobiosurg 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