APTUS® Forearm Shaft Plates And APTUS® Wrist 2.5 System

Plate, Fixation, Bone

Medartis AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus® Forearm Shaft Plates And Aptus® Wrist 2.5 System.

Pre-market Notification Details

• Device ID: K193554
• 510k Number: K193554
• Device Name: APTUS® Forearm Shaft Plates And APTUS® Wrist 2.5 System
• Classification: Plate, Fixation, Bone
• Applicant: Medartis AG Hochbergerstrasse 60E Basel, CH Ch-4057
• Contact: Andrea Kiefer-schweizer
• Correspondent: Kevin A. Thomas; PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
• Product Code: HRS
• Subsequent Product Code: HWC
• Subsequent Product Code: KTT
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-20
• Decision Date: 2020-02-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630037862666	K193554	000
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