FDA 510(k) Applications Submitted by K2M, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K190584 03/06/2019 CAYMAN LP Plate System K2m, Inc.
K133402 11/06/2013 K2M MODULAR HOOKS K2M, INC.
K120031 01/04/2012 CHESAPEAKE SPINAL SYSTEM K2M, INC.
K120099 01/12/2012 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
K160208 01/28/2016 NILE Alternative Fixation 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.
K120656 03/05/2012 EVEREST SPINAL SYSTEM K2M, INC.
K130699 03/14/2013 ALEUTIAN SPINAL SYSTEM K2M, INC.
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.
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.
K101084 04/19/2010 CASPIAN SPINAL SYSTEM K2M, 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.
K141147 05/05/2014 RANGE 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.
K111439 05/24/2011 CHESAPEAKE (CERVICAL COMPONENTS) K2M, INC.
K131533 05/25/2013 CAYMAN MI PLATE SYSTEM K2M, INC.
K121630 06/04/2012 RANGE SPINAL SYSTEM K2M, INC.
K131784 06/18/2013 RANGE 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.
K172009 07/03/2017 Cascadia Interbody System K2M, Inc.
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.
K132757 09/04/2013 EVEREST SPINAL SYSTEM K2M, INC.
K122877 09/19/2012 RANGE SPINAL SYSTEM, SMALL STATURE K2M, INC.
K162664 09/26/2016 Pyrenees Cervical Plate System K2M, Inc.
K112920 10/03/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC.
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.
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.
K103440 11/23/2010 EVEREST SPINAL SYSTEM K2M, INC.
K143350 11/24/2014 Nile Alternative Fixation K2M, Inc.
K133614 11/25/2013 ALEUTIAN IBF SYSTEM K2M, INC.
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.
K141873 07/11/2014 RANGE/MESA/DENALI SPINAL SYSTEM K2M, INC.
K190179 02/01/2019 SAHARA Stabilization System K2M, Inc.
K201006 04/17/2020 K2M Navigation Instruments K2M, Inc.
K192911 10/15/2019 Brainlab Compatible K2M Navigation Instruments K2M, Inc.
K193129 11/12/2019 Yukon OCT Spinal System K2M, Inc.
K193203 11/20/2019 MOJAVE Expandable Interbody System K2M, Inc.
K211320 04/30/2021 CAPRI Corpectomy Cage System K2M, Inc.
K063399 11/09/2006 ALEUTIAN SPACER SYSTEM K2M, INC.
K063544 11/24/2006 MODIFICATION TO PYRENEES CERVICAL PLATE SYSTEM K2M, INC.
K080302 02/05/2008 CAYMAN BUTTRESS PLATE SYSTEM K2M, INC.
K092211 07/22/2009 CHESAPEAKE SPINAL SYSTEM K2M, INC.
K082698 09/15/2008 ALEUTIAN IBF SYSTEM K2M, INC.
K080024 01/04/2008 ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 K2M, INC.
K100061 01/11/2010 CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX K2M, INC.
K070229 01/24/2007 RANGE SPINAL SYSTEM K2M, INC.
K080611 03/04/2008 MESA SPINAL SYSTEM K2M, INC.
K080792 03/20/2008 K2M COCR ROD K2M, INC.
K081107 04/18/2008 CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS K2M, INC.
K091253 04/29/2009 THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS K2M, INC.
K081380 05/16/2008 THORACOLUMBAR, LUMBAR AND SACRAL PLATES AND 6.0 AND 7.0 MM BONE SCREWS K2M, INC.
K081381 05/16/2008 RANGE SPINAL SYSTEM, LARGE DENALI SCREWS K2M, INC.
K092474 08/12/2009 PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2M, INC.
K092640 08/27/2009 CASPIAN SPINAL SYSTEM K2M, INC.
K082769 09/22/2008 MESA AND RANGE SPINAL SYSTEMS K2M, INC.
K072914 10/12/2007 NATURAL BRIDGE LP TRANSVERSE CONNECTORS K2M, INC.


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