EASYMADE-TI— 510(k) K252251
Substantially EquivalentCG 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 plates for repairing defects in the skull. "TI" likely means titanium, a common material for these implants. Preformed plates are shaped before surgery, often from the patient's CT data, instead of being bent to fit in the operating room.
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
- Code GXN
- Device class
- Class 2
- Regulation
- 21 CFR 882.5330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code GXN
view allMore clearances from CG Bio Co., Ltd.
view allAdverse events under product code GXN
product code GXN- Injury
- 208
- Total
- 208
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.