APTUS Clavicle System

Plate, Fixation, Bone

Medartis AG

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

Pre-market Notification Details

• Device ID: K192984
• 510k Number: K192984
• Device Name: APTUS Clavicle 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: HTN
• Subsequent Product Code: HTY
• Subsequent Product Code: HWC
• Subsequent Product Code: MBI
• CFR Regulation Number: 888.3030 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-10-25
• Decision Date: 2020-01-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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