FDA 510(k) Applications Submitted by MEDTRONIC SOFAMOR DANEK

FDA 510(k) Number Submission Date Device Name Applicant
K171031 04/06/2017 CRESCENTÖ Spinal System Medtronic Sofamor Danek
K161210 04/28/2016 RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems Medtronic Sofamor Danek
K171468 05/18/2017 FUSE Spinal System Medtronic Sofamor Danek
K091442 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K091797 06/17/2009 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K082236 08/07/2008 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K081038 04/11/2008 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK
K082342 08/15/2008 MODIFICATION TO CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K070527 02/23/2007 ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK
K080805 03/21/2008 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K071033 04/12/2007 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K081297 05/07/2008 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K071813 07/02/2007 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK
K072265 08/15/2007 PROGENIX DMB PUTTY MEDTRONIC SOFAMOR DANEK
K063248 10/26/2006 ARCUATE VERTEBRAL AUGMENTATION SYSTEM MEDTRONIC SOFAMOR DANEK
K063670 12/11/2006 MODIFICATIONS TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K063491 11/17/2006 T2 SCEPTOR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K062427 08/18/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K060719 03/17/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K060794 03/23/2006 PROGENIX DBM PUTTY AND PASTE MEDTRONIC SOFAMOR DANEK
K062606 09/05/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K094025 12/30/2009 CRESCENT SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K123246 10/17/2012 CD HORIZON SPIRE Z SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K172199 07/21/2017 ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium Medtronic Sofamor Danek
K100175 01/21/2010 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K094042 12/30/2009 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK
K170679 03/06/2017 CD HORIZON« Spinal System, Medtronic Reusable Instruments for Use with the IPC« POWEREASE« System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION« and IPC« POWEREASE« Systems Medtronic Sofamor Danek
K172328 08/02/2017 SOVEREIGNÖ Spinal System Medtronic Sofamor Danek
K173125 09/29/2017 T2 STRATOSPHEREÖ Expandable Corpectomy System Medtronic Sofamor Danek
K110676 03/10/2011 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K113252 11/03/2011 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK
K121982 07/06/2012 SOVEREIGN SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K080083 01/11/2008 INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K100214 01/25/2010 CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK
K140276 02/03/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K090353 02/11/2009 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK
K110472 02/18/2011 SI-FIX SACROILIAC JOINT FUSION SYSTEM MEDTRONIC SOFAMOR DANEK
K070742 03/16/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K091445 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K111457 05/26/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K062073 07/21/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K072429 08/29/2007 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K083026 10/10/2008 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K063417 11/13/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K090740 03/20/2009 MODIFICATION TO: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K101772 06/24/2010 TSRH(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K103049 10/15/2010 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K090390 02/17/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K090714 03/18/2009 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K081080 04/16/2008 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K082112 07/28/2008 T2 XVBR SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K083071 10/15/2008 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K093434 11/04/2009 VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K080462 02/20/2008 PROGENIX DBM PUTTY MEDTRONIC SOFAMOR DANEK
K081784 06/24/2008 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK
K082002 07/14/2008 PROGENIX PLUS MEDTRONIC SOFAMOR DANEK
K082166 07/31/2008 MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK
K071942 07/13/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K111525 06/01/2011 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK
K091813 06/18/2009 INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K113529 11/30/2011 CD HORIZON VOYAGER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K061274 05/08/2006 VENTURE ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK
K021761 05/29/2002 PREMIER ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK
K060081 01/10/2006 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K020155 01/17/2002 DYNA-LOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K050117 01/18/2005 MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK
K040167 01/26/2004 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K060203 01/26/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K030327 01/31/2003 ZEPHIR ANTERIOR CERVICAL SYSTEM MEDTRONIC SOFAMOR DANEK
K050282 02/07/2005 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K060415 02/17/2006 MODIFICATION TO: SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K040422 02/18/2004 MODIFICATION TO VERTE-STACK MEDTRONIC SOFAMOR DANEK
K040536 03/02/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K020709 03/05/2002 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K040583 03/05/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K060615 03/07/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K030735 03/10/2003 MODIFIED VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K030736 03/10/2003 VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES MEDTRONIC SOFAMOR DANEK
K030816 03/14/2003 MSD CABLE REDUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K021061 04/02/2002 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K040962 04/14/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K021226 04/18/2002 MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK
K041030 04/21/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K041118 04/29/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K051105 05/02/2005 BASIS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK
K021461 05/07/2002 ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK
K041197 05/07/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K061304 05/10/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K021791 05/31/2002 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K041452 06/01/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K031780 06/10/2003 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K031782 06/10/2003 GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS MEDTRONIC SOFAMOR DANEK
K041556 06/10/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K031833 06/13/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K032033 07/01/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K032037 07/01/2003 CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) MEDTRONIC SOFAMOR DANEK
K041777 07/01/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K061915 07/06/2006 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K041862 07/09/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K032265 07/23/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052054 07/29/2005 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052144 08/08/2005 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052180 08/10/2005 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K042167 08/11/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052187 08/11/2005 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K042210 08/16/2004 MSD SILO SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K042235 08/18/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK
K032560 08/20/2003 ARROWHEAD SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052376 08/30/2005 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K052402 09/01/2005 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K042498 09/14/2004 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K042499 09/14/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK
K042524 09/17/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K052609 09/22/2005 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052734 09/30/2005 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K052747 09/30/2005 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K042789 10/06/2004 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K042790 10/06/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K033271 10/10/2003 DYNALOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K023415 10/11/2002 MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K042886 10/19/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K052931 10/19/2005 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K042962 10/27/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043020 11/03/2004 GLAXY 3.2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K053101 11/04/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043053 11/05/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043151 11/15/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043321 12/02/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043343 12/06/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K053474 12/13/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K053483 12/15/2005 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K043488 12/17/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K033926 12/18/2003 HOURGLASS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK
K043602 12/29/2004 QUADRANT RETRACTOR SYSTEM MEDTRONIC SOFAMOR DANEK
K034056 12/30/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043561 12/27/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K030601 02/25/2003 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K051320 05/20/2005 SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K061579 06/07/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K061635 06/12/2006 MSD BIPOLAR FORCEPS MEDTRONIC SOFAMOR DANEK
K031888 06/18/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K033322 10/15/2003 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K023570 10/24/2002 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K023797 11/14/2002 LAURAIN DEWALD ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK
K043566 12/27/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K043568 12/27/2004 EQUESTRA FLUID DELIVERY SYSTEM MEDTRONIC SOFAMOR DANEK
K014296 12/31/2001 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K082463 08/27/2008 PROGENIX MEDTRONIC SOFAMOR DANEK
K082917 09/30/2008 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK
K082918 09/30/2008 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK
K153373 11/23/2015 CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device Medtronic Sofamor Danek
K103731 12/22/2010 CAPSTONE R SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K101168 04/26/2010 LEGEND POWER ADAPTER MODEL: 6475000 MEDTRONIC SOFAMOR DANEK


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