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 IDK192984
510k NumberK192984
Device Name:APTUS Clavicle System
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  
Subsequent Product CodeHTN
Subsequent Product CodeHTY
Subsequent Product CodeHWC
Subsequent Product CodeMBI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-25
Decision Date2020-01-24
Summary:summary

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