FDA 510(k) Applications Submitted by Nancy Giezen

FDA 510(k) Number Submission Date Device Name Applicant
K120031 01/04/2012 CHESAPEAKE SPINAL SYSTEM K2M, INC.
K170055 01/06/2017 CAPRI Corpectomy Cage System K2M
K120099 01/12/2012 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
K160125 01/20/2016 Cascadia Interbody System K2M
K160208 01/28/2016 NILE Alternative Fixation Spinal System K2M, Inc.
K150325 02/09/2015 Range/Denali/Mesa Spinal System K2M, Inc
K130330 02/11/2013 RANGE SPINAL SYSTEM K2M, INC.
K180376 02/12/2018 K2M Patient Specific Rods K2M, Inc.
K150481 02/24/2015 Cascadia Interbody System K2M, Inc.
K160547 02/26/2016 Cascadia Interbody System K2M
K140529 03/04/2014 EVEREST SPINAL SYSTEM K2M, LLC
K120656 03/05/2012 EVEREST SPINAL SYSTEM K2M, INC.
K130699 03/14/2013 ALEUTIAN SPINAL SYSTEM K2M, INC.
K180665 03/14/2018 SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2M, LLC.
K110843 03/25/2011 ALEUTIAN SPACER SYSTEM K2M, INC.
K100851 03/26/2010 RANGE SPINAL SYSTEM K2M, INC.
K120899 03/26/2012 RANGE SPINAL SYSTEM, UNIT ROD K2M, INC.
K180777 03/26/2018 K2M Expandable Interbody System K2M, Inc.
K140765 03/27/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC.
K230846 03/28/2023 iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System Conformis, Inc.
K121016 04/04/2012 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
K110991 04/08/2011 MESA SPINAL SYSTEM (KEYSTONE RODS) K2M, INC.
K131030 04/12/2013 RANGE SPINAL SYSTEM K2M, INC.
K161028 04/12/2016 K2M Growing Spine System K2M, Inc.
K171097 04/13/2017 MOJAVE Expandable Interbody System K2M, Inc.
K150983 04/14/2015 Pyrenees Cervical Plate System K2M
K101084 04/19/2010 CASPIAN SPINAL SYSTEM K2M, INC.
K201023 04/20/2020 iTotal« Identity Posterior Stabilized Knee Replacement System Conformis, Inc.
K111135 04/22/2011 PYRENEES CERVICAL PLATE SYSTEM (TRANSLATIONAL PLATES) K2M, INC.
K181119 04/27/2018 Range (Denali and Mesa) Spinal Systems K2M, Inc.
K181188 05/03/2018 EVEREST Spinal System K2M Inc.
K171321 05/04/2017 K2M Navigation Instruments K2M
K141147 05/05/2014 RANGE SPINAL SYSTEM K2M, INC.
K151216 05/06/2015 Everest Spinal System K2M, Inc
K101302 05/10/2010 ALEUTIAN IBF SYSTEM K2M, INC.
K111294 05/10/2011 SANTORINI SPINAL SYSTEM K2M, INC.
K161332 05/12/2016 NILE Proximal Fixation Spinal System K2M, INC.
K141284 05/16/2014 CASPIAN SPINAL SYSTEM K2M, INC.
K171444 05/16/2017 YUKON OCT Spinal System K2M, Inc.
K161369 05/17/2016 EVEREST Spinal System K2M, Incorporated
K111439 05/24/2011 CHESAPEAKE (CERVICAL COMPONENTS) K2M, INC.
K131533 05/25/2013 CAYMAN MI PLATE SYSTEM K2M, INC.
K171556 05/30/2017 K2M Navigation Instruments K2M
K151481 06/02/2015 Sahara Stabilization System K2M, INC
K121630 06/04/2012 RANGE SPINAL SYSTEM K2M, INC.
K171704 06/08/2017 CAPRI Corpectomy Cage System K2M
K131784 06/18/2013 RANGE SPINAL SYSTEM K2M, INC.
K181603 06/19/2018 EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System K2M Inc.
K121808 06/20/2012 CASIAN, 3.5/4.5 CONNECTORS K2M, INC.
K171832 06/20/2017 Range/Denali/Mesa Spinal System K2M, Inc.
K151727 06/26/2015 Everest Spinal System K2M, INC
K172009 07/03/2017 Cascadia Interbody System K2M, Inc.
K172104 07/12/2017 Ozark(tm) Cervical Plate System K2M Inc.
K181890 07/13/2018 Brainlab Compatible K2M Navigation Instruments K2M
K112037 07/18/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
K152015 07/21/2015 Pyrenees Cervical Plate System K2M, INC.
K142016 07/25/2014 CAPRI K2M, INC.
K132361 07/30/2013 EVEREST SPINAL SYSTEM K2M, INC.
K162264 08/11/2016 Cascadia Interbody System K2M, Inc.
K142212 08/12/2014 Pyrenees Cervical Plate System K2M, Inc
K152281 08/12/2015 Pyrenees Cervical Plate System K2M
K182182 08/13/2018 YUKON OCT Spinal System K2M
K142360 08/25/2014 Everest Spinal System K2M, Inc
K202484 08/31/2020 Cordera Hip System Conformis, Inc.
K132757 09/04/2013 EVEREST SPINAL SYSTEM K2M, INC.
K142487 09/04/2014 Chesapeake Stabilization System K2M Inc.
K182473 09/10/2018 PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems K2M Inc.
K142558 09/11/2014 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M
K122877 09/19/2012 RANGE SPINAL SYSTEM, SMALL STATURE K2M, INC.
K162664 09/26/2016 Pyrenees Cervical Plate System K2M, Inc.
K172941 09/26/2017 CASCADIA Interbody System K2M
K152872 09/30/2015 K2M Fenestrated Tap System K2M
K112920 10/03/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
K153031 10/19/2015 RANGE/DENALI/MESA Spinal System K2M, Incorporated
K113138 10/25/2011 ALEUTIAN SYSTEM K2M, INC.
K133288 10/25/2013 CASPIAN OCT SPINAL SYSTEM K2M, INC.
K103169 10/27/2010 ALEUTTIAN K2M, INC.
K103232 11/02/2010 CASPIAN SPINAL SYSTEM K2M, INC.
K123412 11/06/2012 RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS K2M, INC.
K193105 11/08/2019 iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System Conformis, Inc.
K173508 11/13/2017 Everest Spinal System K2M
K113329 11/14/2011 K2M, PYRENEES CERVICAL PLATE SYSTEM K2M, INC.
K133494 11/14/2013 CHESAPEAKE SPINAL SYSTEM K2M, INC.
K093534 11/16/2009 MODIFICATION TO CASPIAN SPINAL SYSTEM K2M, INC.
K143334 11/20/2014 Range/Denali/Mesa Spinal System K2M, INC
K103440 11/23/2010 EVEREST SPINAL SYSTEM K2M, INC.
K153370 11/23/2015 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M, Incorporated
K955388 11/24/1995 ACE-DUPONT COMPOSITE RINGS ACE MEDICAL CO.
K143350 11/24/2014 Nile Alternative Fixation K2M, Inc.
K133614 11/25/2013 ALEUTIAN IBF SYSTEM K2M, INC.
K163364 11/30/2016 MOJAVE Expandable Interbody System K2M
K153526 12/09/2015 Pyrenees Cervical Plate System K2M
K113654 12/12/2011 CASPIAN K2M, INC.
K133944 12/23/2013 RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM K2M, INC.
K103797 12/27/2010 K2M COCR WIRE K2M, INC.


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