FDA 510(k) Applications Submitted by Lee Grant

FDA 510(k) Number Submission Date Device Name Applicant
K080083 01/11/2008 INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K100214 01/25/2010 CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK
K130177 01/25/2013 ANATOMIC PEEK CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K150200 01/29/2015 CD HORIZON Growth Rod Conversion Set MEDTRONIC SOFAMOR DANEK USA, INCORPORATED
K140276 02/03/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K170347 02/03/2017 CD HORIZONÖ Fenestrated Screw Set Medtronic Sofamor Danek USA
K090353 02/11/2009 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK
K110472 02/18/2011 SI-FIX SACROILIAC JOINT FUSION SYSTEM MEDTRONIC SOFAMOR DANEK
K160528 02/25/2016 ANATOMIC PEEK PTC Cervical Fusion System MEDTRONIC SOFAMOR DANEK, USA, INC.
K070742 03/16/2007 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK
K140750 03/25/2014 SHILLA GROWTH GUIDANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K151128 04/28/2015 CAPSTONE Spinal System, CLYDESDALE Spinal System MEDTRONIC SOFAMOR DANEK USA, INC
K091445 05/15/2009 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K111457 05/26/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K171938 06/28/2017 KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set Medtronic
K061938 07/10/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K062073 07/21/2006 VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K062133 07/26/2006 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SPINAL AND BIOLOGICS DIV
K162212 08/08/2016 DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K072317 08/20/2007 MODIFICATION TO:TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K072429 08/29/2007 MODIFICATION TO TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K123027 09/28/2012 CAPSTONE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K102886 09/30/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC.
K083026 10/10/2008 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K193011 10/29/2019 CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek USA, Inc.
K063417 11/13/2006 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK
K133577 11/21/2013 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC
K073291 11/23/2007 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K143471 12/05/2014 VERTEX Reconstruction System Medtronic Sofamor Danek USA, Inc
K133904 12/20/2013 CD HORIZON SPINAL SYSTEM GROWTH ROD SET MEDTRONIC SOFAMOR DANEK USA


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