APTUS® Proximal Humerus System

Plate, Fixation, Bone

Medartis AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus® Proximal Humerus System.

Pre-market Notification Details

• Device ID: K181425
• 510k Number: K181425
• Device Name: APTUS® Proximal Humerus System
• Classification: Plate, Fixation, Bone
• Applicant: Medartis AG Hochbergerstrasse 60E Basel, CH Ch-4057
• Contact: Andrea Schweizer
• Correspondent: Kevin A. Thomas; PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
• Product Code: HRS
• Subsequent Product Code: HTY
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-31
• Decision Date: 2018-08-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630037808534	K181425	000
07630037872771	K181425	000
07630037872788	K181425	000
07630037873785	K181425	000
07630037896159	K181425	000
07630037896173	K181425	000
07630037808503	K181425	000
07630037808510	K181425	000
07630037808527	K181425	000
07630037872764	K181425	000