ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

Orthosis, Spondylolisthesis Spinal 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 IDK140948
510k NumberK140948
Device Name:ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva,  CH 1215
ContactFranck Pennesi
CorrespondentFranck Pennesi
SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva,  CH 1215
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-14
Decision Date2014-05-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.