FDA applicant
Osteonic Co., Ltd.
FDA records 20 decisions for Osteonic Co., Ltd. (Seoul, KR) from 2015 to 2026: 20 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 87 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 54 predicates, 13 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 Osteonic Co., 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 2015.
Planning a device like Osteonic 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