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 IDK111127
510k NumberK111127
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 Received2011-04-21
Decision Date2011-08-11
Summary:summary

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