APTUS® Coronoid 2.0

Plate, Fixation, Bone

Medartis AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus® Coronoid 2.0.

Pre-market Notification Details

• Device ID: K161861
• 510k Number: K161861
• Device Name: APTUS® Coronoid 2.0
• 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
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-06
• Decision Date: 2017-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630008491390	K161861	000
07630008491369	K161861	000
07630037894209	K161861	000
07630037894193	K161861	000