Solco Biomedical Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
4CIS® Chiron Spinal Fixation System510(k)Nov 26, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Nov 26, 2024
4CIS Chiron Spinal Fixation System510(k)Jun 1, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jun 1, 2022