FDA applicant
GS Medical Co., Ltd.
FDA records 20 decisions for GS Medical Co., Ltd. (Cheongju-Si, KR) from 2006 to 2026: 20 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 101 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 37 predicates, 15 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 GS Medical 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 2007.
Planning a device like GS Medical 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