ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Orthosis, Spinal Pedicle Fixation

SPINEART

The following data is part of a premarket notification filed by Spineart with the FDA for Romeo Posterior Osteosynthesis System.

Pre-market Notification Details

Device IDK093936
510k NumberK093936
Device Name:ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva,  CH 1215
ContactFranck Pennesi
CorrespondentFranck Pennesi
SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva,  CH 1215
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-22
Decision Date2010-03-11
Summary:summary

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