ANAX OCT Spinal System— 510(k) K251725

Name: FDA 510(k) clearance K251725
Creator: U.S. Food and Drug Administration
Published: 2025-06-25

Substantially Equivalent

Cg Medtech Co., Ltd.

FDA 510(k) clearance K251725 for ANAX OCT Spinal System, Substantially Equivalent on 2025-06-25. Applicant: Cg Medtech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Cg Medtech Co., Ltd.
Product code: Code NKG
Device class: Class 2
Regulation: 21 CFR 888.3075
Advisory panel: Orthopedic
Date received: 2025-06-05
Decision date: 2025-06-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Uijeongbu-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NKG

product code NKG

Death: 15
Injury: 1,090
Malfunction: 529
Total: 1,634

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.