APTUS Cannulated Compression Screws, APTUS Headed Cannulated Compression Screws, APTUS K-Wire System

Screw, Fixation, Bone

Medartis AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus Cannulated Compression Screws, Aptus Headed Cannulated Compression Screws, Aptus K-wire System.

Pre-market Notification Details

Device IDK202589
510k NumberK202589
Device Name:APTUS Cannulated Compression Screws, APTUS Headed Cannulated Compression Screws, APTUS K-Wire System
ClassificationScrew, Fixation, Bone
Applicant Medartis AG Hochbergerstrasse 60E Basel,  CH Ch-4057
ContactAndrea Kiefer-schweizer
CorrespondentLauren M. Wessell
PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego,  CA  92130
Product CodeHWC  
Subsequent Product CodeHTN
Subsequent Product CodeHTY
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2020-11-06

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