EASYMADE-TI— 510(k) K252251

Name: FDA 510(k) clearance K252251
Creator: U.S. Food and Drug Administration
Published: 2026-04-09

Substantially Equivalent

CG Bio Co., Ltd.

FDA 510(k) clearance K252251 for EASYMADE-TI, Substantially Equivalent on 2026-04-09. Applicant: CG Bio Co., Ltd.. Device class: 2.

Summary

EASYMADE-TI is a cranioplasty plate, filed under GXN: preformed, non-alterable cranioplasty plates. "TI" may mean titanium, but the record doesn't give the material.

Class II, 21 CFR 882.5330. The Neurology panel reviewed it as a Traditional 510(k).

CG Bio filed from Seoul, South Korea. Review took 265 days (July 18, 2025 to April 9, 2026).

Clearance details

Applicant: CG Bio Co., Ltd.
Product code: Product code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2025-07-18
Decision date: 2026-04-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

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.