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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K163221
Device Name Mazor X
Applicant
Mazor Robotics , Ltd.
7 Haeshel St.
Caesarea,  IL 3088900
Applicant Contact Ayelet Matia
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
20 Hatas St.
Kfar Saba,  IL
Correspondent Contact Ahava Stein
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Codes
HAW   LLZ  
Date Received11/16/2016
Decision Date 04/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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