MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS

Plate, Fixation, Bone

MEDXPERT GMBH

The following data is part of a premarket notification filed by Medxpert Gmbh with the FDA for Medxpert P.e.s. (pectus Exacvatum System), Medxpert Stratos.

Pre-market Notification Details

Device IDK073556
510k NumberK073556
Device Name:MEDXPERT P.E.S. (PECTUS EXACVATUM SYSTEM), MEDXPERT STRATOS
ClassificationPlate, Fixation, Bone
Applicant MEDXPERT GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg,  DE 78570
ContactFranz Menean
CorrespondentFranz Menean
MEDXPERT GMBH GRIESWEG 47 Muhlheim, Baden-wurttemberg,  DE 78570
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-19
Decision Date2008-06-24
Summary:summary

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