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. |
|
|