CG Bio Co., Ltd.

FDA Regulatory Profile

CG Bio Co., Ltd. appears in FDA public data with 0 recalls, 6 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on June 23, 2026.

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253199CURASYS 2 (EMDN0003)June 23, 2026
K252251EASYMADE-TIApril 9, 2026
K250582COLONNADE Posterior Screw Fixation SystemMay 8, 2025
K222229Advanced LumFix Spinal Fixation SystemMay 25, 2023
K160731LumFix Spinal Fixation SytemOctober 4, 2016
K122490KULAVACNovember 13, 2013