FDA 510(k) Applications Submitted by Medtronic Sofamor Danek USA, Inc

FDA 510(k) Number Submission Date Device Name Applicant
K180851 04/02/2018 VERTEXÖ Reconstruction System Medtronic Sofamor Danek USA, Inc
K160418 02/16/2016 PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc
K143375 11/25/2014 CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments MEDTRONIC SOFAMOR DANEK USA, INC
K143141 11/03/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K143569 12/16/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K151172 05/01/2015 MASTERGRAFT Contain MEDTRONIC SOFAMOR DANEK USA, INC
K162494 09/07/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K152623 09/14/2015 ATLANTIS Anterior Cervical Plate System MEDTRONIC SOFAMOR DANEK USA, INC
K163581 12/20/2016 Navigated ELEVATE Inserter, Navigated Disc Prep Instruments MEDTRONIC SOFAMOR DANEK USA, INC
K151128 04/28/2015 CAPSTONE Spinal System, CLYDESDALE Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K133577 11/21/2013 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC
K143471 12/05/2014 VERTEX Reconstruction System Medtronic Sofamor Danek USA, Inc
K111942 07/08/2011 TSRH SPINAL SYSTEMS MEDTRONIC SOFAMOR DANEK USA, INC
K152277 08/12/2015 PIVOX(tm) Oblique Lateral Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K150178 01/26/2015 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC
K153438 11/27/2015 PERIMETER C (Titanium) Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K150231 02/02/2015 Navigated Disc Prep Instruments and CAPSTONE Trials MEDTRONIC SOFAMOR DANEK USA, INC
K142450 09/02/2014 DIVERGENCE Anterior Cervical Fusion System MEDTRONIC SOFAMOR DANEK USA, INC
K143628 12/22/2014 Navigated Vertex Select Instruments MEDTRONIC SOFAMOR DANEK USA, INC
K152338 08/19/2015 VERTEX(r) Reconstruction System MEDTRONIC SOFAMOR DANEK USA, INC


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