CG Bio Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
CURASYS 2 (EMDN0003)510(k)Jun 23, 2026General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Jun 23, 2026
EASYMADE-TI510(k)Apr 9, 2026Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 9, 2026
COLONNADE Posterior Screw Fixation System510(k)May 8, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 8, 2025
Advanced LumFix Spinal Fixation System510(k)May 25, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 25, 2023