VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS

Orthopedic Stereotaxic Instrument

MEDOS INTERNATIONAL SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Viper And Expedium Navigated Instruments.

Pre-market Notification Details

Device IDK120867
510k NumberK120867
Device Name:VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
ClassificationOrthopedic Stereotaxic Instrument
Applicant MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
ContactLaura Bleyendaal
CorrespondentLaura Bleyendaal
MEDOS INTERNATIONAL SARL 325 Paramount Drive Raynham,  MA  02767
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-22
Decision Date2012-09-20
Summary:summary

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