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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 K193011
Device Name CD Horizon™ Fenestrated Screw Set
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Lee Grant
Correspondent
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Lee Grant
Regulation Number888.3070
Classification Product Code
NKB  
Date Received10/29/2019
Decision Date 01/10/2020
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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