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Spine Wave, Inc.

59 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Dynamo™ Spinal Cement; Salvo® Spine System (K260286)Spine Wave, Inc.2026-06-15
Exceed® Biplanar Expandable Interbody System (K261159)Spine Wave, Inc.2026-05-29
Testa TP Pivoting Spacer System (K243816)Spine Wave, Inc.2025-06-27
Annex® 2 Adjacent Level System (K251131)Spine Wave, Inc.2025-06-06
Salvo® Robotic Navigation Instruments (K243514)Spine Wave, Inc.2025-04-03
Salvo® Spine System (K240685)Spine Wave, Inc.2024-05-06
Exceed™ Biplanar Expandable Interbody System (K231275)Spine Wave, Inc.2023-07-25
Salvo® Spine System (K222362)Spine Wave, Inc.2022-08-29
Salvo® Spine System (K202476)Spine Wave, Inc.2020-11-05
Spine Wave Navigated Instruments (K192526)Spine Wave, Inc.2019-10-10
Salvo™ Spine System (K191045)Spine Wave, Inc.2019-07-10
Salvo™ Spine System (K182954)Spine Wave, Inc.2018-12-12
Spine Wave Navigated Instruments (K181596)Spine Wave, Inc.2018-10-24
Proficient® Posterior Cervical Spine System (K181440)Spine Wave, Inc.2018-07-30
Proficient® Posterior Cervical Spine System (K172594)Spine Wave, Inc.2017-12-15
Paramount Anterior Cervical Cage System (K173175)Spine Wave, Inc.2017-11-01
CapSure® PS System (K172175)Spine Wave, Inc.2017-08-16
Leva Anterior Expandable Spacer System (K163246)Spine Wave, Inc.2017-04-06
Spine Wave Anterior Cervical Spine System (K162760)Spine Wave, Inc.2017-02-16
Proficient™ Posterior Cervical Spine System (K162639)Spine Wave, Inc.2017-02-07
Leva® Anterior Interbody System (K161993)Spine Wave, Inc.2016-11-22
Leva Spacer System (K153222)Spine Wave, Inc.2016-04-15
Sniper (R) Spine System (K160003)Spine Wave, Inc.2016-02-26
Spine Wave Gen II Expandable Interbody System (K152620)Spine Wave, Inc.2016-01-15
Sniper Spine System (K152174)Spine Wave, Inc.2015-08-31
Sniper Spine System (K151813)Spine Wave, Inc.2015-07-31
Leva Spacer System (K151581)Spine Wave, Inc.2015-07-09
Leva(TM) Spacer System (K150285)Spine Wave, Inc.2015-03-05
StaXx(R) XD System (K142996)Spine Wave, Inc.2015-02-19
LEVA (TM) SPACER SYSTEM (K141980)Spine Wave, Inc.2015-01-26
Proficient (TM) Facet Screw Spine System (K142980)Spine Wave, Inc.2015-01-16
ABACUS (TM) SPACER SYSTEM (K142101)Spine Wave, Inc.2014-10-23
ABACUS TM SPACER SYSTEM (K140007)Spine Wave, Inc.2014-04-07
ANNEXTM ADJACENT LEVEL SYSTEM (K132403)Spine Wave, Inc.2014-01-10
STAXX(R) SYSTEM (K133207)Spine Wave, Inc.2013-12-06
STAXX IBL SYSTEM (K132719)Spine Wave, Inc.2013-10-04
STAXX IBL SYSTEM (K131071)Spine Wave, Inc.2013-08-20
CAPSURE PS SYSTEM (K132154)Spine Wave, Inc.2013-08-09
STAXX(R) IB SYSTEM (K123461)Spine Wave, Inc.2013-04-11
CAPSURE(R) PS SYSTEM (K122233)Spine Wave, Inc.2012-10-11
STAXX XD SYSTEM (K121889)Spine Wave, Inc.2012-08-29
CAPSURE(R) PS SYSTEM (K120646)Spine Wave, Inc.2012-06-07
STAXX(R) XD SYSTEM (K111418)Spine Wave, Inc.2011-12-13
CAPSURE(R) PS SYSTEM (K111913)Spine Wave, Inc.2011-08-31
STAXX XDL SYSTEM (K102315)Spine Wave, Inc.2011-08-19
STAXXSD SYSTEM (K111469)Spine Wave, Inc.2011-07-19
STAXX(R) XD SYSTEM (K102682)Spine Wave, Inc.2010-11-30
STAXX XD SYSTEM (K101288)Spine Wave, Inc.2010-09-10
MIS SYSTEM (K100605)Spine Wave, Inc.2010-06-04
MODIFICATION TO CAPSURE PS SYSTEM (K100122)Spine Wave, Inc.2010-02-12
STAXX XD SYSTEM (K090315)Spine Wave, Inc.2009-09-03
CAPSURE PS SYSTEM (K083743)Spine Wave, Inc.2009-01-13
CAPSURE(R) PS SYSTEM (K083353)Spine Wave, Inc.2008-12-11
CAPSURE PS (R) SPINE SYSTEM (K081228)Spine Wave, Inc.2008-05-12
MODIFICATION TO STAXX FX SYSTEM (K063606)Spine Wave, Inc.2007-04-13
CAPSURE PEDICLE SCREW SYSTEM (K070245)Spine Wave, Inc.2007-04-05
STAXX FX SYSTEM (K053336)Spine Wave, Inc.2006-07-03
STAXX XD SYSTEM (K052670)Spine Wave, Inc.2006-04-27
WAFER SYSTEM (K033303)Spine Wave, Inc.2004-06-24

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Every clearance here is in the API, with alerts when new ones post.