Osartis GmbH 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
Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds510(k)Nov 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 20, 2024
BonOs Inject, Pedicle screw kits, Cement pusher510(k)May 18, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 18, 2021
BonOs HV, BonOs MV, BonOs LV510(k)Mar 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 19, 2021
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta510(k)Mar 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 19, 2021