G21, S.R.L. FDA Approvals

0 new drug approvals and 3 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
SpaceFix Shoulder Spacer510(k)Sep 15, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 15, 2025
SpaceFlex Acetabular Cup510(k)Mar 23, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 23, 2023
SpaceFlex Shoulder510(k)Feb 17, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 17, 2021