APTUS Foot System

Plate, Fixation, Bone

MEDARTIS AG

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

Pre-market Notification Details

• Device ID: K142581
• 510k Number: K142581
• Device Name: APTUS Foot System
• Classification: Plate, Fixation, Bone
• Applicant: MEDARTIS AG HOCHBERGERSTRASSE 60E Basel, CH Ch-4051
• 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: 2014-09-15
• Decision Date: 2015-04-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07630037866688	K142581	000
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