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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