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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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catalyft ls expandable interbody system with titan nanolock surface technology Medtronic Sofamor Danek USA, Inc. K223153 12/16/2022
anteralign spinal system with titan nanolock surface technology Medtronic Sofamor Danek USA K214010 04/12/2022
catalyft™ pl expandable interbody system navigated instruments, anteralign™ tl spinal system with titan nanolock™ surface technology navigated instruments, and cd horizon™ solera™ voyager™ spinal system navigated, guided, and powered drivers Medtronic Sofamor Danek USA, INC. K214011 02/09/2022
anteralign spinal system with titan nanolock surface technology Medtronic Sofamor Danek USA, INC. K212524 12/08/2021
catalyft ls expandable interbody system Medtronic Sofamor Danek USA, Inc. K212653 11/19/2021
endoskeleton tc interbody system, endoskeleton tcs interbody system, endoskeleton ta interbody system, endoskeleton tas & tas hyp interbody system, endoskeleton tl interbody system, endoskeleton tl hyp. interbody system, endoskeleton to interbody system, endoskeleton tt interbody system Medtronic Sofamor Danek USA, Inc. K211258 05/26/2021
catalyft pl expandable interbody system Medtronic Sofamor Danek, USA Inc. K210425 05/24/2021
adaptix interbody system with titan nanolock surface technology Medtronic Sofamor Danek K201267 08/26/2020
capstone spinal system, clydesdale ptc spinal system, crescent spinal system, crescent spinal system titanium, divergence-l anterior/oblique lumbar fusion system Medtronic Sofamor Danek, USA Inc. K191788 03/23/2020
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
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