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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 K210637
Device Name CD Horizon™ Spinal System
Applicant
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Shweta Sharma
Correspondent
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Shweta Sharma
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
HBE   KWP   KWQ   OLO  
Date Received03/03/2021
Decision Date 04/30/2021
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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