510(k) K253213 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
SAGI Cervical Cage System
| Applicant | ZheJiang Decans Medical Devices Co., Ltd., Jiaxing, CN |
| Decision | Substantially Equivalent, Apr 20, 2026 |
| Received | Sep 29, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253213
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.