SAGI Cervical Cage System— 510(k) K253213

Name: FDA 510(k) clearance K253213
Creator: U.S. Food and Drug Administration
Published: 2026-04-20

Substantially Equivalent

ZheJiang 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.

Clearance details

Applicant: ZheJiang Decans Medical Devices Co., Ltd.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-09-29
Decision date: 2026-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

view all

K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

More clearances from ZheJiang Decans Medical Devices Co., Ltd.

view all

K253046 — HERA Interlocking Intramedullary Nailing System2026-06-16
K253195 — TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems2026-06-02
K252930 — AQUA Laminoplasty Systems2026-05-27
K253130 — Dione PEEK Screw System2026-05-27
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.