RENAISSANCE SYSTEM


Device Classification Name

neurological stereotaxic instrument

510(k) Number K110911
Device Name RENAISSANCE SYSTEM
Applicant
MAZOR ROBOTICS LTD
20 hata’as st.
kfar saba, 

IL

44425

Applicant Contact ahava stein
Correspondent
MAZOR ROBOTICS LTD
20 hata’as st.
kfar saba, 

IL

44425

Correspodent Contact ahava stein
Regulation Number 882.4560
Classification Product Code
HAW  
Subsequent Product Code
LLZ  
Date Received 03/31/2011
Decision Date 04/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No