K253213
- 510(k) number
- K253213
- Device name
- SAGI Cervical Cage System
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd. CN
- Product code
- OVE — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2026-04-20
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253213.pdf
Official FDA record: K253213
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.