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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 10 of 27 Results
ProductCode: NQP Applicant: MEDTRONIC SOFAMOR DANEK Decision Date To: 04/19/2024
 
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cd horizon™ astute™ spinal system; cd horizon™ growth rod conversion set; cd horizon™ spinal system; cd horizon™ fenestrated screw set; colorado 2™ spinal system; gdlh™ posterior spinal system; shilla™ growth guidance system; tenor™ spinal system Medtronic Sofamor Danek USA, Inc. K221646 10/04/2022
cd horizon™ spinal system Medtronic Sofamor Danek USA, INC. K203678 01/15/2021
cd horizon™ astute™ spinal system Medtronic Sofamor Danek, USA Inc. K191066 10/03/2019
cd horizon™ spinal system Medtronic Sofamor Danek USA, Inc. K182928 01/11/2019
cd horizon spire z spinal system MEDTRONIC SOFAMOR DANEK K123246 11/16/2012
cd horizon spinal system MEDTRONIC SOFAMOR DANEK, INC. K111510 09/15/2011
modification to:cd horizon spinal system MEDTRONIC SOFAMOR DANEK USA, INC. K092325 12/15/2009
modification to cd horizon spinal system MEDTRONIC SOFAMOR DANEK USA, INC. K091974 09/02/2009
cd horizon spinal system MEDTRONIC SOFAMOR DANEK K091442 07/15/2009
cd horizon spinal system MEDTRONIC SOFAMOR DANEK K082236 10/10/2008
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