Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EASYMADE-TI

K-Number: K252251 · 2026-04-09

ApplicantCG Bio Co., Ltd.
Decision Date2026-04-09
Product CodeGXN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EASYMADE-TI is a medical device manufactured by CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under approval number K252251. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASYMADE-TI?

EASYMADE-TI is a medical device that received FDA 510(k) clearance on 2026-04-09. It is manufactured by CG Bio Co., Ltd.. The 510(k) number is K252251.

When was EASYMADE-TI approved by the FDA?

EASYMADE-TI received FDA 510(k) clearance on 2026-04-09, under approval number K252251.

What company makes EASYMADE-TI?

EASYMADE-TI is manufactured by CG Bio Co., Ltd..

What is the FDA product code for EASYMADE-TI?

The FDA product code for EASYMADE-TI is GXN.

Other Devices by CG Bio Co., Ltd.

K160731LumFix Spinal Fixation Sytem K222229Advanced LumFix Spinal Fixation System K250582COLONNADE Posterior Screw Fixation System

Related Devices (Code: GXN)

K160707CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K171507CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K161090Cranial PSIOssdsign AB K180064OsteoFab Patient Specific Cranial DeviceOxford Performance Materials, Inc. K180513CustomizedBone ServiceFin-Ceramica Faenza S.P.A. K170410Longeviti PMMA Static Cranial ImplantLongeviti Neuro Solutions, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑