Onkos Surgical FDA Approvals

0 new drug approvals and 5 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
ELEOSx Limb Salvage System510(k)Apr 5, 2024Orthopedic	Orthopedic	510(k)Unknown (Direct)	Apr 5, 2024
My3D® Personalized Pelvic Reconstruction510(k)Jul 6, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 6, 2022
ELEOS Limb Salvage System510(k)Jul 28, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 28, 2021
ELEOS Limb Salvage System with BioGrip510(k)Jun 9, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 9, 2021
ELEOS Limb Salvage System510(k)Feb 5, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 5, 2021