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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 53 Results
ProductCode: MAX Applicant: MEDTRONIC SOFAMOR DANEK Decision Date To: 05/18/2024
 
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adaptix interbody system with titan nanolock surface technology Medtronic Sofamor Danek K201267 08/26/2020
anatomic peek cervical fusion system cornerstone psr cervical fusion system peek prevail cervical interbody device capst MEDTRONIC SOFAMOR DANEK, INC. K122037 03/22/2013
anatomic peek™ cervical fusion system, anatomic peek™ ptc cervical fusion system, capstone™ spinal system, capstone ptc™ spinal system, capstone control™ spinal system, capstone control ptc™ spinal system, clydesdale™ spinal system, clydesdale ptc™ spinal system, cornerstone™ psr cervical fusion sy Medtronic Sofamor Danek USA, Inc K192502 01/22/2020
anteralign spinal system with titan nanolock surface technology Medtronic Sofamor Danek USA K214010 04/12/2022
anteralign spinal system with titan nanolock surface technology Medtronic Sofamor Danek USA, INC. K212524 12/08/2021
artic-l 3d ti spinal system with tionic technology, artic-xl 3d ti spinal system with tionic technology Medtronic Sofamor Danek USA, Inc. K171689 10/05/2017
artic-l 3d ti spinal system with tionic technology, artic-xl 3d ti spinal system with tionic technology Medtronic Sofamor Danek USA, Inc K190959 07/03/2019
capstone control spinal system MEDTRONIC SOFAMOR DANEK USA, INC. K120368 04/09/2012
capstone control spinal system, capstone control ptc spinal system Medtronic Sofamor Danek USA, Inc. K171107 09/26/2017
capstone control™ spinal system Medtronic Sofamor Danek USA, INC. K190165 05/06/2019
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