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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K173249
Device Name CD HORIZON™ Spinal System
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Applicant Contact Ankit K. Shah
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl
Memphis,  TN  38132
Correspondent Contact Ankit K. Shah
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received10/10/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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