Inion OY 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
Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System510(k)Nov 7, 2025Dental	Dental	510(k)Substantially Equivalent (Traditional)	Nov 7, 2025
Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System510(k)Jul 11, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Jul 11, 2025
Inion CompressOn Screw510(k)Jan 13, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 13, 2021