510(k) K252542 ยท NKB Thoracolumbosacral Pedicle Screw System
LEO Spinal System
| Applicant | ZheJiang Decans Medical Devices Co., Ltd., Jiaxing City, CN |
| Decision | Substantially Equivalent, Apr 29, 2026 |
| Received | Aug 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252542
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.