FDA applicant
Orthopeasia Co., Ltd.
FDA records 1 decision for Orthopeasia Co., Ltd. (Bangpla, Bangplee, Samutprakarn, TH) in 2024: 1 510(k) clearance. All are in product code NKB (Thoracolumbosacral Pedicle Screw System). Its devices cite 2 predicates, 0 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 Orthopeasia Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Orthopeasia 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