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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 K230064
Device Name Mazor X System (Mazor X Stealth Edition)
Applicant
Mazor Robotics , Ltd.
1 Haeshel St. (Bldg. C)
Caesarea Business Park,  IL 3079830
Applicant Contact Rishi Sinha
Correspondent
Mazor Robotics , Ltd.
1 Haeshel St. (Bldg. C)
Caesarea Business Park,  IL 3079830
Correspondent Contact Marina Shkedy
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
LLZ  
Date Received01/09/2023
Decision Date 04/07/2023
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
Recalls CDRH Recalls
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