APTUS Wrist Arthrodesis Plates

Plate, Fixation, Bone

Medartis AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Wrist Arthrodesis Plates.

Pre-market Notification Details

Device IDK192297
501k NumberK192297
Device Name:APTUS Wrist Arthrodesis Plates
ClassificationPlate, Fixation, Bone
Applicant Medartis AG Hochbergerstrasse 60E Basel,  CH Ch-4057
ContactAndrea Kiefer-schweizer
CorrespondentKevin A. Thomas
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-23
Decision Date2019-11-08

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