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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 K182121
Device Name CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Erikka Edwardsen
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Erikka Edwardsen
Regulation Number882.4560
Classification Product Code
OLO  
Date Received08/06/2018
Decision Date 11/02/2018
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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