Solco Biomedical Company India Private Limited 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 BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM510(k)Dec 19, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 19, 2022
4CIS SARA Spine System, 4CIS VERTU Spine System510(k)Feb 18, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 18, 2021