Uni-C Cervical Cage System— 510(k) K252774
Substantially EquivalentZheJiang Decans Medical Devices Co., Ltd.
FDA 510(k) clearance K252774 for Uni-C Cervical Cage System, Substantially Equivalent on 2026-04-15. Applicant: ZheJiang Decans Medical Devices Co., Ltd.. Device class: 2.
Summary
ZheJiang Decans Medical Devices' Uni-C Cervical Cage System is filed under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).
Class II, 21 CFR 888.3080. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
ZheJiang Decans filed from Jiaxing City, China. The record shows 225 calendar days from receipt to decision (September 2, 2025 to April 15, 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 City, 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.