Easymade-Ti
FDA 510(k) K252251 · CG Bio Co., Ltd.
510(k) numberK252251
Submission
- Device name
- Easymade-Ti
- Applicant
- CG Bio Co., Ltd.
Seoul, KR - Received
- July 18, 2025
- Decision date
- April 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | KLS-Martin L.P. | 11/10/2025SE |
| K240567 | CustomizedBone ServiceGXN · Special | Fin-Ceramica Faenza S.P.A. | 03/28/2024SE |
| K231920 | Longeviti ClearFit OTS Cranial ImplantGXN · Special | Longeviti Neuro Solutions, LLC | 11/09/2023SE |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN · Traditional | Kontour(XiAn) Medical Technology Co., Ltd. | 10/28/2022SE |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | Medcad | 08/26/2022SE |
| K210099 | Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional | Meticuly Co., Ltd. | 12/21/2021SE |
More from Meticuly Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253199 | Curasys 2 (EMDN0003)OMP · Traditional | 06/23/2026SE |
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| K222229 | Advanced LumFix Spinal Fixation SystemNKB · Traditional | 05/25/2023SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | 10/04/2016SE |
| K122490 | KulavacOMP · Traditional | 11/13/2013SE |
Questions and answers
When was Easymade-Ti cleared by the FDA?
Easymade-Ti (K252251) received a 510(k) decision of Substantially Equivalent on April 9, 2026, 265 days after the submission was received.
What is the product code of K252251?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.