FDA applicant
Gbs Commonwealth Co., Ltd.
FDA records 14 decisions for Gbs Commonwealth Co., Ltd. (Geumcheon-Gu, KR) from 2018 to 2023: 14 510(k) clearances. Most are in product codes ODP (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 92 days from receipt to decision, against 107 for FDA’s reviews in the same codes and years. Its devices cite 39 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 Gbs Commonwealth Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
6in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Gbs Commonwealth 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