Signus Medizintechnik 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
CYLOX® ST510(k)Feb 11, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 11, 2025
Signus Tetris St; Signus Tetris R St510(k)Sep 11, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 11, 2024
COSY Cervicothoracic Occipital Rod-Screw System510(k)Nov 18, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 18, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System510(k)Mar 10, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 10, 2022