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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name neurological stereotaxic instrument
510(k) Number K113228
Device Name RENAISSANCE SYSTEM
Original Applicant
MAZOR ROBOTICS LTD
20 hata'as st.
kfar saba,  IL 44425
Original Contact ahava stein
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
LLZ  
Date Received11/01/2011
Decision Date 12/01/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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