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

FDA 510(k) Number Submission Date Device Name Applicant
K211441 05/10/2021 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, INC.
K223153 10/06/2022 Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology Medtronic Sofamor Danek USA, Inc.
K214011 12/22/2021 CatalyftÖ PL Expandable Interbody System Navigated Instruments, AnteralignÖ TL Spinal System with Titan nanoLOCKÖ Surface Technology Navigated Instruments, and CD HorizonÖ SoleraÖ VoyagerÖ Spinal System Navigated, Guided, and Powered Drivers Medtronic Sofamor Danek USA, INC.
K182119 08/06/2018 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc.
K182436 09/07/2018 POWEREASE System Medtronic Sofamor Danek USA, Inc.
K173249 10/10/2017 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, Inc.
K183197 11/19/2018 PYRAMESHÖ Implant System Medtronic Sofamor Danek USA, INC.
K153589 12/16/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC.
K110543 02/25/2011 CRESCENT (R) SPINAL SYSTEM TITANIUM MEDTRONIC SOFAMOR DANEK USA, INC.
K132328 07/26/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K152248 08/10/2015 CD HORIZON Spinal System Medtronic Sofamor Danek USA, Inc.
K142559 09/11/2014 ELEVATE Spinal System Medtronic Sofamor Danek USA, Inc.
K163181 11/14/2016 TRANSLACEÖ Spinal Tethering System Medtronic Sofamor Danek USA, Inc.
K133645 11/27/2013 PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K113528 11/30/2011 CLYDESDALE(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K153463 12/01/2015 CD HORIZON Spinal System, IPC POWEREASE System MEDTRONIC SOFAMOR DANEK USA, INC.
K130646 03/11/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K100967 04/08/2010 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K121760 06/15/2012 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K092325 08/04/2009 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K121680 06/07/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K091974 07/01/2009 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K112555 09/02/2011 CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K102555 09/07/2010 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K122862 09/17/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K082732 09/18/2008 MODIFICATION TO: CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K113174 10/27/2011 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K071416 05/21/2007 PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K123656 11/28/2012 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K123906 12/19/2012 VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K062986 09/29/2006 MEDTRONIC GRAFT DELIVERY SYRINGE MEDTRONIC SOFAMOR DANEK USA, INC.
K190840 04/01/2019 Medtronic Transportation / Sterilization Cassettes Medtronic Sofamor Danek USA, INC.
K222383 08/05/2022 AnteralignÖ LS Spinal System with Titan nanoLOCKÖ Surface Technology MAZORX Stealth(TM) Edition Medtronic Sofamor Danek USa, Inc.
K212524 08/11/2021 Anteralign Spinal System with Titan nanoLOCK Surface Technology Medtronic Sofamor Danek USA, INC.
K141494 06/06/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K182121 08/06/2018 CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition Medtronic Sofamor Danek USA, Inc.
K203291 11/09/2020 CD Horizon Spinal System Instruments Medtronic Sofamor Danek USA, INC.
K133650 11/27/2013 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K120368 02/06/2012 CAPSTONE CONTROL SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K171107 04/14/2017 CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System Medtronic Sofamor Danek USA, Inc.
K112405 08/22/2011 CLYDESDALES SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K133205 10/18/2013 CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K123270 10/19/2012 POWEREASE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K133653 11/27/2013 ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K190165 01/31/2019 Capstone ControlÖ Spinal System Medtronic Sofamor Danek USA, INC.
K163301 11/22/2016 CD HORIZON« Spinal System Medtronic Sofamor Danek USA, Inc.
K162680 09/26/2016 SOVEREIGN« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC.
K182885 10/15/2018 AtlantisÖ Anterior Cervical Plate, DivergenceÖ Anterior Cervical Fusion System, PremierÖ Anterior Cervical Plate, VentureÖ Anterior Cervical Plate, ZephirÖ Anterior Cervical Plate System and ZevoÖ Anterior Cervical Plate System Medtronic Sofamor Danek USA, Inc.
K140374 02/14/2014 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK USA, INC.
K140375 02/14/2014 MASTERGRAFT PUTTY, MASTERGRAFT STRIP MEDTRONIC SOFAMOR DANEK USA, INC.
K131673 06/07/2013 MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT MEDTRONIC SOFAMOR DANEK USA, INC.
K171689 06/07/2017 ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology Medtronic Sofamor Danek USA, Inc.
K110259 01/28/2011 ARCHITEX SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K211258 04/26/2021 Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Medtronic Sofamor Danek USA, Inc.
K211958 06/24/2021 CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc.
K232141 07/18/2023 CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) Medtronic Sofamor Danek USA, Inc.
K130640 03/11/2013 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K141632 06/18/2014 ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K223764 12/15/2022 INFINITY OCT System Medtronic Sofamor Danek USA, Inc.
K131669 06/07/2013 PERIMETER INTERBODY FUSION DEVICE MEDTRONIC SOFAMOR DANEK USA, INC.
K180700 03/16/2018 KYPHON HV-R Bone Cement Medtronic Sofamor Danek USA, Inc.
K152457 08/28/2015 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC.
K182497 09/12/2018 OsteoCool RF Ablation System Medtronic Sofamor Danek USA, Inc.
K130177 01/25/2013 ANATOMIC PEEK CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K140750 03/25/2014 SHILLA GROWTH GUIDANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
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.
K193011 10/29/2019 CD HorizonÖ Fenestrated Screw Set Medtronic Sofamor Danek USA, Inc.
K073291 11/23/2007 CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K150135 01/21/2015 DIVERGENCE-L Anterior/Oblique Lumbar Fusion System MEDTRONIC SOFAMOR DANEK USA, INC.
K080429 02/19/2008 MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K141604 06/16/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K142591 09/15/2014 CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK USA, INC.
K142648 09/17/2014 SPINEDESIGN Spine Surgery Planning (Software Application) MEDTRONIC SOFAMOR DANEK USA, INC.
K143019 10/20/2014 CD HORIZON Spinal System, IPC POWEREASE System Medtronic Sofamor Danek USA, Inc.
K153442 11/27/2015 CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATIO Medtronic Sofamor Danek USA, Inc.
K120271 01/30/2012 ARTISAN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K212653 08/23/2021 Catalyft LS Expandable Interbody System Medtronic Sofamor Danek USA, Inc.
K203678 12/17/2020 CD HORIZONÖ Spinal System Medtronic Sofamor Danek USA, INC.
K082728 09/18/2008 VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K141605 06/16/2014 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K132584 08/16/2013 PERIMETER C SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K073285 11/23/2007 PEEK PREVAIL CERVICAL INTERBODY DEVICE MEDTRONIC SOFAMOR DANEK USA, INC.
K100779 03/19/2010 SUSTAIN SPACE MAINTENANCE SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K123568 11/20/2012 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K162379 08/24/2016 CD HORIZON« Spinal System MEDTRONIC SOFAMOR DANEK USA, INC.
K110522 02/23/2011 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K092087 07/09/2009 MEDTRONIC DENTAL TCP MEDTRONIC SOFAMOR DANEK USA, INC.
K192336 08/28/2019 Navigated Anterolateral Disc Prep Instruments Medtronic Sofamor Danek USA, INC.
K182928 10/22/2018 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, Inc.
K140454 02/24/2014 NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS MEDTRONIC SOFAMOR DANEK USA, INC.
K050981 04/19/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K050079 01/13/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K050809 03/31/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K051039 04/25/2005 BASIS SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K011443 05/11/2001 THREADED CEMENT RESTRICTOR (CR) TITANIUM MEDTRONIC SOFAMOR DANEK USA, INC.
K041460 06/02/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K051674 06/23/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K002103 07/12/2000 SIMPLICITY SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K052261 08/19/2005 MODIFICATION TO: VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K000094 01/13/2000 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K010529 02/23/2001 TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA MEDTRONIC SOFAMOR DANEK USA, INC.
K010528 02/23/2001 TITANIUM CEMENT RESTRICTOR MATERIAL PEEK MEDTRONIC SOFAMOR DANEK USA, INC.
K010632 03/02/2001 BUTTERFLY PLATE FUNCTION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K021170 04/12/2002 TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K012506 08/06/2001 MASTERGRAFT RESORBABLE CERAMIC GRANULES MEDTRONIC SOFAMOR DANEK USA, INC.
K031655 05/28/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K010701 03/08/2001 MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER MEDTRONIC SOFAMOR DANEK USA, INC.
K130335 02/11/2013 MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX MEDTRONIC SOFAMOR DANEK USA, INC.
K101074 04/19/2010 MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K231090 04/17/2023 Zevo Anterior Cervical Plate System Medtronic Sofamor Danek USA, Inc.
K221646 06/06/2022 CD HORIZONÖ ASTUTEÖ SPINAL SYSTEM; CD HORIZONÖ Growth Rod Conversion Set; CD HORIZONÖ SPINAL SYSTEM; CD HorizonÖ Fenestrated Screw Set; COLORADO 2Ö SPINAL System; GDLHÖ POSTERIOR SPINAL SYSTEM; SHILLAÖ Growth Guidance System; TENORÖ SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc.
K141599 06/13/2014 DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K132639 08/23/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K132471 08/07/2013 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K123809 12/11/2012 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K181111 04/27/2018 Navigated INFINITY Instruments Medtronic Sofamor Danek USA, Inc.
K173338 10/23/2017 Navigated INFINITYÖ Instruments Medtronic Sofamor Danek USA, Inc.
K163375 12/01/2016 INFINITYÖ OCT System Medtronic Sofamor Danek USA, Inc.
K100976 04/08/2010 T2 XVBR 1.5 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K091883 06/24/2009 T2 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC.
K201407 05/28/2020 CD HorizonÖ Spinal System Medtronic Sofamor Danek USA, INC.
K202328 08/17/2020 CD Horizon Spinal System Medtronic Sofamor Danek USA, Inc.
K152241 08/10/2015 Medtronic Transportation/Sterilization Cassettes Medtronic Sofamor Danek USA, Inc.


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