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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 K051676
Device Name SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
Applicant
MAZOR SURGICAL TECHNOLOGIES LTD.
BEIT HAPA'AMON BOX 124
20 HATA'AS (ROOM 213)
KFAR SABA,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
MAZOR SURGICAL TECHNOLOGIES LTD.
BEIT HAPA'AMON BOX 124
20 HATA'AS (ROOM 213)
KFAR SABA,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/23/2005
Decision Date 09/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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