Medynus, Inc. 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
IMPEACE and IMPEACE-Uni Anterior Cervical Plate System510(k)Mar 3, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 3, 2022
Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage510(k)Sep 23, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 23, 2021
Goblin and Goblin LS Pedicle Screw Systems510(k)Apr 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 19, 2021