FDA 510(k) Applications Submitted by NUVASIVE, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K211757 |
06/07/2021 |
Simplify Disc |
NuVasive, Inc. |
K140003 |
01/02/2014 |
COROENT SMALL INTERBODY SYSTEM |
NUVASIVE, INC. |
K140162 |
01/22/2014 |
AP EXPANDABLE XLIF SYSTEM |
NUVASIVE, INC. |
K130868 |
03/29/2013 |
NUVASIVE DECADE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K131025 |
04/12/2013 |
ARCHON ANTERIOR CERVICAL PLATE SYSTEM |
NUVASIVE, INC. |
K121837 |
06/22/2012 |
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM |
NUVASIVE, INC. |
K123045 |
10/01/2012 |
BRIGADE STANDALONE SYSTEM |
NUVASIVE, INC. |
K111410 |
05/19/2011 |
NUVASIVE LONG LATERAL SPINAL SYSTEM |
NUVASIVE, INC. |
K121619 |
06/01/2012 |
NUVASIVE POLYAXIAL SPINAL SCREWS |
NUVASIVE, INC. |
K111811 |
06/27/2011 |
BENDINI(TM) SPINAL ROD BENDING SYSTEM |
NUVASIVE, INC. |
K122081 |
07/16/2012 |
NUVASIVE LONG LATERAL SPINAL SYSTEM |
NUVASIVE, INC. |
K122352 |
08/03/2012 |
NUVASIVE PRECEPT SPINAL SYSTEM |
NUVASIVE, INC. |
K112718 |
09/19/2011 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
K112717 |
09/19/2011 |
NUVASIVE NVJJB SYSTEM |
NUVASIVE, INC. |
K103750 |
12/23/2010 |
NUVASIVE TRAVERSE PLATE SYSTEM |
NUVASIVE, INC. |
K102514 |
09/01/2010 |
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM |
NUVASIVE, INC. |
K090176 |
01/23/2009 |
NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM |
NUVASIVE, INC. |
K090298 |
02/06/2009 |
NUVASIVE NEURO VISION SYSTEM |
NUVASIVE, INC. |
K090981 |
04/07/2009 |
MODIFICATION TO: NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
K091071 |
04/14/2009 |
NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K091502 |
05/21/2009 |
NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
K091623 |
06/03/2009 |
LAMINOPLASTY FIXATION SYSTEM |
NUVASIVE, INC. |
K083028 |
10/10/2008 |
MODIFICATION TO: NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
K083341 |
11/12/2008 |
NUVASIVE HELIX-T ACP SYSTEM |
NUVASIVE, INC. |
K140319 |
02/10/2014 |
COROENT TI-C SYSTEM |
NUVASIVE, INC. |
K131723 |
06/12/2013 |
COROENT SINGLE TAB SYSTEM |
NUVASIVE, INC. |
K141665 |
06/23/2014 |
NuVasive CoRoent System |
NUVASIVE, INC. |
K141968 |
07/21/2014 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
K020411 |
02/07/2002 |
NUVASIVE TRIAD FACET SCREW SYSTEM |
NUVASIVE, INC. |
K040543 |
03/02/2004 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K020853 |
03/15/2002 |
NUVASIVE MESH |
NUVASIVE, INC. |
K001323 |
04/26/2000 |
NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW |
NUVASIVE, INC. |
K041447 |
06/01/2004 |
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM |
NUVASIVE, INC. |
K032083 |
07/07/2003 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K032180 |
07/17/2003 |
NUVASIVE CEMENT RESTRICTOR |
NUVASIVE, INC. |
K032476 |
08/12/2003 |
NUVASIVE MESH |
NUVASIVE, INC. |
K013257 |
10/01/2001 |
HEMI-ARC SURGICAL NAVIGATOR |
NUVASIVE, INC. |
K023319 |
10/04/2002 |
NUVASIVE MASH |
NUVASIVE, INC. |
K033546 |
11/12/2003 |
NUVASIVE SPINAL SYSTEM |
NUVASIVE, INC. |
K070148 |
01/16/2007 |
GRAFT CONTAINMENT DEVICE |
NUVASIVE, INC. |
K070273 |
01/29/2007 |
MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K060225 |
01/30/2006 |
NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
K071329 |
05/11/2007 |
NUVASIVE HELIX ACP SYSTEM |
NUVASIVE, INC. |
K081377 |
05/16/2008 |
NUVASIVE SURGICAL MESH SYSTEM |
NUVASIVE, INC. |
K071435 |
05/23/2007 |
NUVASIVE OCT SYSTEM |
NUVASIVE, INC. |
K051384 |
05/27/2005 |
MODIFICATION TO: NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K081611 |
06/09/2008 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
K061789 |
06/26/2006 |
LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K061778 |
06/26/2006 |
NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
K051718 |
06/27/2005 |
NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K071795 |
07/02/2007 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
K082070 |
07/22/2008 |
NUVASIVE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K042034 |
07/29/2004 |
NUVASIVE MAXCESS LIGHT GUIDE |
NUVASIVE, INC. |
K062317 |
08/09/2006 |
MODIFICATION TO NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
K082332 |
08/14/2008 |
NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
K052210 |
08/15/2005 |
NUVASIVE COROENT EXTENSURE SYSTEM |
NUVASIVE, INC. |
K072339 |
08/20/2007 |
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM |
NUVASIVE, INC. |
K072343 |
08/21/2007 |
NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K062590 |
09/01/2006 |
NUVASIVE ACP4 SYSTEM |
NUVASIVE, INC. |
K062765 |
09/29/2006 |
MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM |
NUVASIVE, INC. |
K053215 |
11/17/2005 |
SURGICAL MESH SYSTEM |
NUVASIVE, INC. |
K073278 |
11/21/2007 |
SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
K073275 |
11/21/2007 |
NUVASIVE HELIX MINI ACP SYSTEM |
NUVASIVE, INC. |
K043405 |
12/10/2004 |
NUVASIVE COROENT SYSTEM |
NUVASIVE, INC. |
K053581 |
12/23/2005 |
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM |
NUVASIVE, INC. |
K173117 |
09/29/2017 |
NuVasive« VersaTieÖ System |
NuVasive, Inc. |
K223731 |
12/13/2022 |
NuVasive Modulus-C Interbody System |
Nuvasive, Inc. |
K132014 |
07/01/2013 |
GSB GLOBAL SPINAL BALANCE SYSTEM |
NUVASIVE, INC. |
K142205 |
08/11/2014 |
NuVasive X-CORE(R) Expandable VBR System |
NUVASIVE, INC. |
K133052 |
09/27/2013 |
AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
K002677 |
08/28/2000 |
NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
NUVASIVE, INC. |
K013215 |
09/26/2001 |
MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM |
NUVASIVE, INC. |
K100043 |
01/08/2010 |
COROENT XLR STANDALONE SYSTEM |
NUVASIVE, INC. |
K120918 |
03/27/2012 |
NUVASIVE COROENT TITANIUM SYSTEM |
NUVASIVE, INC. |
K131238 |
05/01/2013 |
AFFIX SPINOUS PROCESS PLATE SYSTEM |
NUVASIVE, INC. |
K101284 |
05/07/2010 |
FACET SCREW SYSTEM |
NUVASIVE, INC. |
K111597 |
06/08/2011 |
DISPOSABLE STIMULATING ELECTRODE |
NUVASIVE, INC. |
K121815 |
06/20/2012 |
NUVASIVE SAGE LATERAL PLATE SYSTEM |
NUVASIVE, INC. |
K111866 |
06/30/2011 |
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM |
NUVASIVE, INC. |
K092287 |
07/29/2009 |
NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM |
NUVASIVE, INC. |
K112561 |
09/02/2011 |
NUVASIVE COROENT NO-PROFILE SYSTEM |
NUVASIVE, INC. |
K102547 |
09/03/2010 |
COROENT INTERLOCK SYSTEM |
NUVASIVE, INC. |
K122742 |
09/07/2012 |
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM |
NUVASIVE, INC. |
K093319 |
10/23/2009 |
NUVASIVE VUEPOINT OCT SYSTEM |
NUVASIVE, INC. |
K123307 |
10/24/2012 |
NUVASIVE NVM5 SYSTEM |
NUVASIVE, INC. |
K093804 |
12/11/2009 |
NUVASIVE HELIX REVOLUTION ACP SYSTEM |
NUVASIVE, INC. |
K094054 |
12/31/2009 |
MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE |
NUVASIVE, INC. |
K990324 |
02/02/1999 |
NUVASIVE GUIDED SPINAL ARTHROSCOPY SYSTEM |
NUVASIVE, INC. |
K992782 |
08/19/1999 |
NUVASIVE SPINAL ARTHROSCOPE, MODELS 0, 30 AND 70 DEGREES |
NUVASIVE, INC. |
K994308 |
12/21/1999 |
NUVASIVE TOWNLEY FACET SCREW |
NUVASIVE, INC. |
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