FDA applicant
L&K BIOMED Co., Ltd.
FDA records 58 decisions for L&K BIOMED Co., Ltd. (Yongin-Si, KR) from 2010 to 2026: 58 510(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 34 days from receipt to decision, against 82 for FDA’s reviews in the same codes and years. Its devices cite 238 predicates, 120 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 L&K BIOMED Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like L&K BIOMED Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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