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

FDA 510(k) Number Submission Date Device Name Applicant
K132700 08/29/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK, INC.
K133216 10/18/2013 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K131888 06/25/2013 T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE MEDTRONIC SOFAMOR DANEK, INC.
K122037 07/11/2012 ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM PEEK PREVAIL CERVICAL INTERBODY DEVICE CAPST MEDTRONIC SOFAMOR DANEK, INC.
K122591 08/24/2012 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K121764 06/15/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K132897 09/16/2013 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K122433 08/10/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K112473 08/26/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K102807 09/28/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K070173 01/18/2007 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K063100 10/10/2006 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE MEDTRONIC SOFAMOR DANEK, INC.
K121191 04/19/2012 VERTEX RCCONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K141824 07/07/2014 MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK, INC.
K062447 08/22/2006 TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K062879 09/26/2006 TRAVERSE OCT SPINAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K062254 08/04/2006 AXIS FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K062807 09/19/2006 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K063083 10/10/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K140449 02/24/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K251193 04/17/2025 GraftonÖ DBM; Grafton PlusÖ DBM Paste; MagnifuseÖ Bone Graft Medtronic Sofamor Danek, Inc.
K243706 11/29/2024 Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules Medtronic Sofamor Danek, Inc.
K093058 09/30/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K122513 08/17/2012 CLEARED UNDER GRAFTON II EDBM MEDTRONIC SOFAMOR DANEK, INC.
K111510 06/01/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K061938 07/10/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K123027 09/28/2012 CAPSTONE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K102886 09/30/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K092676 09/01/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K110063 01/10/2011 SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K123691 12/03/2012 MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM) MEDTRONIC SOFAMOR DANEK, INC.
K050484 02/25/2005 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K040072 01/14/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K010181 01/19/2001 CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION MEDTRONIC SOFAMOR DANEK, INC.
K020247 01/24/2002 COLORADO 2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K020426 02/08/2002 MSD WIRE SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K050439 02/22/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K040483 02/25/2004 EQUESTRA FLUID DELIVERY SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K030840 03/17/2003 MODIFICATION TO HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K030875 03/20/2003 MODIFICATION TO COLORADO 2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K030932 03/25/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K020986 03/27/2002 MASTERGRAFT RESORBABLE CERAMIC MEDTRONIC SOFAMOR DANEK, INC.
K010930 03/28/2001 LIFT VB SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K001066 04/03/2000 CD HORIZON ECLIPSE MEDTRONIC SOFAMOR DANEK, INC.
K021106 04/05/2002 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K001255 04/19/2000 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K011406 05/08/2001 SPINAL MESH SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K041217 05/10/2004 MODIFICATION TO BONE GRAFT WASHER MEDTRONIC SOFAMOR DANEK, INC.
K041282 05/13/2004 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K031533 05/16/2003 VANTAGE ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K021705 05/23/2002 MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K061592 06/08/2006 MODIFICATION TO CD HORIZON SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K061591 06/08/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K022070 06/26/2002 XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K031967 06/26/2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K012081 07/03/2001 DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K042025 07/28/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K032578 08/21/2003 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K022778 08/22/2002 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K042402 09/03/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K042453 09/10/2004 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K042922 10/22/2004 VENTURE ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K033495 11/05/2003 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K013962 12/03/2001 EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K024049 12/09/2002 VERTE-SPAN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K014076 12/11/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K014267 12/27/2001 BUTTERFLY PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K010249 01/26/2001 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K030285 01/28/2003 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K000453 02/11/2000 MODIFICATION TO CD SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K000476 02/14/2000 MODIFICATION TO CD SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K000641 02/25/2000 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K020699 03/01/2002 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K010720 03/12/2001 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K000991 03/28/2000 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K011029 04/05/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K011067 04/09/2001 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K011508 05/16/2001 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K022015 06/20/2002 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K011998 06/27/2001 METRONIC SOFAMOR DANEK CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC.
K022191 07/05/2002 MODIFICATION TO TENOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K012255 07/18/2001 MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC.
K002399 08/07/2000 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K013014 09/07/2001 BLOCK CEMENT RESTRICTOR (CR) - TITANIUM MEDTRONIC SOFAMOR DANEK, INC.
K002931 09/20/2000 METRX SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K023553 10/23/2002 MASTERGRAFT MATRIX MEDTRONIC SOFAMOR DANEK, INC.
K023555 10/23/2002 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K013663 11/06/2001 CEMENT RESTRICTOR MEDTRONIC SOFAMOR DANEK, INC.
K013665 11/06/2001 PYRAMID ANTERIOR PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K003718 12/04/2000 TITANIUM CEMENT RESTRICTOR (TCR) MEDTRONIC SOFAMOR DANEK, INC.
K003780 12/07/2000 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K994239 12/16/1999 ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K003928 12/20/2000 TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K001532 05/17/2000 DYNA-LOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K050082 01/13/2005 CENTERPIECE PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K013829 11/19/2001 MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K081950 07/09/2008 PROGENIX PLUS MEDTRONIC SOFAMOR DANEK, INC.
K140417 02/18/2014 DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK, INC.


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