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 |
| K221180 |
04/25/2022 |
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments |
Medtronic Sofamor Danek USA, INC |
| K190959 |
04/12/2019 |
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology |
Medtronic Sofamor Danek USA, Inc |
| K192502 |
09/12/2019 |
Anatomic PEEKÖ Cervical Fusion System, Anatomic PEEKÖ PTC Cervical Fusion System, CapstoneÖ Spinal System, Capstone PTCÖ Spinal System, Capstone ControlÖ Spinal System, Capstone Control PTCÖ Spinal System, ClydesdaleÖ Spinal System, Clydesdale PTCÖ Spinal |
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 |
| K172328 |
08/02/2017 |
SOVEREIGNÖ 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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