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. |
| 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. |
| K173175 |
09/29/2017 |
Paramount Anterior Cervical Cage System |
Spine Wave, Inc. |
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