FDA 510(k) Applications Submitted by Spine Wave, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K162760 09/30/2016 Spine Wave Anterior Cervical Spine System SPINE WAVE, INC.
K191045 04/19/2019 SalvoÖ Spine System Spine Wave, Inc.
K181440 06/01/2018 Proficient« Posterior Cervical Spine System Spine Wave, Inc.
K181596 06/18/2018 Spine Wave Navigated Instruments Spine Wave, Inc.
K172175 07/19/2017 CapSure« PS System Spine Wave, Inc.
K202476 08/28/2020 Salvo« Spine System Spine Wave, Inc.
K172594 08/29/2017 Proficient« Posterior Cervical Spine System Spine Wave, Inc.
K192526 09/13/2019 Spine Wave Navigated Instruments Spine Wave, Inc.
K182954 10/24/2018 SalvoÖ Spine System Spine Wave, Inc.
K163246 11/18/2016 Leva Anterior Expandable Spacer System SPINE WAVE, INC.
K100605 03/03/2010 MIS SYSTEM SPINE WAVE, INC.
K111469 05/27/2011 STAXXSD SYSTEM SPINE WAVE, INC.
K102315 08/16/2010 STAXX XDL SYSTEM SPINE WAVE, INC.
K151581 06/11/2015 Leva Spacer System SPINE WAVE, INC.
K152620 09/14/2015 Spine Wave Gen II Expandable Interbody System SPINE WAVE, INC.
K153222 11/06/2015 Leva Spacer System SPINE WAVE, INC.
K140007 01/02/2014 ABACUS TM SPACER SYSTEM SPINE WAVE, INC.
K132154 07/12/2013 CAPSURE PS SYSTEM SPINE WAVE, INC.
K122233 07/26/2012 CAPSURE(R) PS SYSTEM SPINE WAVE, INC.
K132403 08/01/2013 ANNEXTM ADJACENT LEVEL SYSTEM SPINE WAVE, INC.
K133207 10/18/2013 STAXX(R) SYSTEM SPINE WAVE, INC.
K160003 01/04/2016 Sniper (R) Spine System SPINE WAVE, INC.
K102682 09/17/2010 STAXX(R) XD SYSTEM SPINE WAVE, INC.
K150285 02/05/2015 Leva(TM) Spacer System SPINE WAVE, INC.
K142101 08/01/2014 ABACUS (TM) SPACER SYSTEM SPINE WAVE, INC.
K142980 10/15/2014 Proficient (TM) Facet Screw Spine System SPINE WAVE, INC.
K142996 10/16/2014 StaXx(R) XD System SPINE WAVE, INC.
K100122 01/15/2010 MODIFICATION TO CAPSURE PS SYSTEM SPINE WAVE, INC.
K090315 02/09/2009 STAXX XD SYSTEM SPINE WAVE, INC.
K120646 03/02/2012 CAPSURE(R) PS SYSTEM SPINE WAVE, INC.
K131071 04/17/2013 STAXX IBL SYSTEM SPINE WAVE, INC.
K081228 04/30/2008 CAPSURE PS (R) SPINE SYSTEM SPINE WAVE, INC.
K101288 05/07/2010 STAXX XD SYSTEM SPINE WAVE, INC.
K111418 05/20/2011 STAXX(R) XD SYSTEM SPINE WAVE, INC.
K121889 06/28/2012 STAXX XD SYSTEM SPINE WAVE, INC.
K111913 07/06/2011 CAPSURE(R) PS SYSTEM SPINE WAVE, INC.
K132719 08/30/2013 STAXX IBL SYSTEM SPINE WAVE, INC.
K123461 11/09/2012 STAXX(R) IB SYSTEM SPINE WAVE, INC.
K083353 11/13/2008 CAPSURE(R) PS SYSTEM SPINE WAVE, INC.
K083743 12/16/2008 CAPSURE PS SYSTEM SPINE WAVE, INC.
K141980 07/21/2014 LEVA (TM) SPACER SYSTEM SPINE WAVE, INC.
K240685 03/12/2024 Salvo« Spine System Spine Wave, Inc.
K251131 04/11/2025 Annex« 2 Adjacent Level System Spine Wave, Inc.
K243514 11/13/2024 Salvo« Robotic Navigation Instruments Spine Wave, Inc.
K070245 01/25/2007 CAPSURE PEDICLE SCREW SYSTEM SPINE WAVE, INC.
K151813 07/02/2015 Sniper Spine System SPINE WAVE, INC.
K222362 08/04/2022 Salvo« Spine System Spine Wave, Inc.
K052670 09/27/2005 STAXX XD SYSTEM SPINE WAVE, INC.
K033303 10/14/2003 WAFER SYSTEM SPINE WAVE, INC.
K053336 12/01/2005 STAXX FX SYSTEM SPINE WAVE, INC.
K063606 12/01/2006 MODIFICATION TO STAXX FX SYSTEM SPINE WAVE, INC.
K231275 05/02/2023 ExceedÖ Biplanar Expandable Interbody System Spine Wave, Inc.
K161993 07/19/2016 Leva« Anterior Interbody System Spine Wave, Inc.
K152174 08/04/2015 Sniper Spine System SPINE WAVE, INC.
K162639 09/22/2016 ProficientÖ Posterior Cervical Spine System Spine Wave, Inc.
K243816 12/12/2024 Testa TP Pivoting Spacer System Spine Wave, Inc.
K173175 09/29/2017 Paramount Anterior Cervical Cage System Spine Wave, Inc.


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