Medartis AG FDA Approvals

0 new drug approvals and 11 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
APTUS Clavicle System 2.8510(k)Jun 5, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 5, 2026
TITAN Nail; APTUS K-Wire System510(k)Apr 17, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 17, 2026
APTUS Shoulder Proximal Humerus System, PentaLock 3.5510(k)Mar 16, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 16, 2026
APTUS Hand System; APTUS Elbow Dorsal Olecranon510(k)Mar 7, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 7, 2025
APTUS Elbow Dorsal Olecranon Plates510(k)Jun 20, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 20, 2024
APTUS Foot System 2.8-3.5510(k)Apr 19, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 19, 2024
APTUS Hand Scaphoid Plates510(k)Mar 21, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 21, 2024
APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension510(k)Nov 3, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 3, 2023
Sterile Products of the APTUS System510(k)Aug 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 18, 2023
APTUS® 3.5 TriLock Straight Plates510(k)Jun 2, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 2, 2023
Medartis APTUS® Ulna Plates510(k)Mar 30, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 30, 2023