Orthonovis, Inc. 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
Cannulated Screw and Kirschner (K wire) System510(k)Oct 2, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 2, 2025
BPS Wrist Fracture System510(k)Mar 17, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 17, 2025
BPS - Bone Fragment Fixation Plates, Screws and Washers510(k)Feb 6, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 6, 2025
BPS Wrist Fracture System510(k)Oct 4, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Oct 4, 2024
ONX Large External Fixation System510(k)Aug 25, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 25, 2022