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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 K201407
Device Name CD Horizon™ Spinal System
Applicant
Medtronic Sofamor Danek USA, INC.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Usman Rashid
Correspondent
Medtronic Sofamor Danek USA, INC.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Raphael McInnis
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
HBE   KWP   KWQ   OLO  
Date Received05/28/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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