APTUS 2.0 RADIAL HEAD SYSTEM

Plate, Fixation, Bone

MEDARTIS AG

The following data is part of a premarket notification filed by Medartis Ag with the FDA for Aptus 2.0 Radial Head System.

Pre-market Notification Details

Device IDK090053
510k NumberK090053
Device Name:APTUS 2.0 RADIAL HEAD SYSTEM
ClassificationPlate, Fixation, Bone
Applicant MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego,  CA  92130
ContactKevin Thomas
CorrespondentKevin Thomas
MEDARTIS AG 11234 EL CAMINO REAL, STE 200 San Diego,  CA  92130
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-01-08
Decision Date2009-04-23
Summary:summary

NIH GUDID Devices

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