CYGNUS-C Standalone ACIF System— 510(k) K222041

Name: FDA 510(k) clearance K222041
Creator: U.S. Food and Drug Administration
Published: 2023-02-09

Substantially Equivalent

GS Medical Co., Ltd.

FDA 510(k) clearance K222041 for CYGNUS-C Standalone ACIF System, Substantially Equivalent on 2023-02-09. Applicant: GS Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-07-11
Decision date: 2023-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cheongju-Si, KR

Download summary PDF View on FDA.gov ↗

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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.