SAGI Cervical Cage System— 510(k) K253213
Substantially EquivalentZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) clearance K253213 for SAGI Cervical Cage System, Substantially Equivalent on 2026-04-20. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.
Summary
ZheJiang Decans Medical Devices' SAGI Cervical Cage System is filed under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).
Class II, 21 CFR 888.3080. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.
ZheJiang Decans filed from Jiaxing, China. Review took 203 calendar days (September 29, 2025 to April 20, 2026).
Clearance details
- Applicant
- ZheJiang Decans Medical Devices Co., Ltd.
- Product code
- Product code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jiaxing, CN
Recent devices under product code OVE
view allMore clearances from ZheJiang Decans Medical Devices Co., Ltd.
view allAdverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.