ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS

Growing Rod System

MEDOS SARL

The following data is part of a premarket notification filed by Medos Sarl with the FDA for Isola And Expedium Growing Spine Systems.

Pre-market Notification Details

Device IDK141509
510k NumberK141509
Device Name:ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
ClassificationGrowing Rod System
Applicant MEDOS SARL 325 Paramount Drive Raynham,  MA  02767
ContactKirsten Lehmuller
CorrespondentKirsten Lehmuller
MEDOS SARL 325 Paramount Drive Raynham,  MA  02767
Product CodePGM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-06
Decision Date2014-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034116587 K141509 000
10705034116570 K141509 000
10705034116563 K141509 000
10705034109145 K141509 000
10705034109138 K141509 000
10705034109121 K141509 000
10705034011790 K141509 000
10705034011783 K141509 000
10705034011776 K141509 000

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