FDA 510(k) Applications Submitted by STRYKER SPINE

FDA 510(k) Number Submission Date Device Name Applicant
K080143 01/22/2008 MODIFICATION TO STRYKER SPINE OASYS SYSTEM STRYKER SPINE
K100737 03/15/2010 MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM STRYKER SPINE
K080773 03/19/2008 THOR ANTERIOR PLATING SYSTEM STRYKER SPINE
K080928 04/02/2008 XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS STRYKER SPINE
K101144 04/23/2010 MODIFICATION TO:RADIUS SPINAL SYSTEM STRYKER SPINE
K091291 05/01/2009 XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD STRYKER SPINE
K102235 08/09/2010 MANTIS SPINAL SYSTEM & MANTIS REDUX SPINAL SYSTEM STRYKER SPINE
K092605 08/24/2009 XIA 4.5 SPINAL SYSTEM STRYKER SPINE
K082608 09/08/2008 RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601 STRYKER SPINE
K083393 11/17/2008 XIA 3 SPINAL SYSTEM STRYKER SPINE
K073437 12/06/2007 THOR ANTERIOR PLATING SYSTEM STRYKER SPINE
K092631 08/26/2009 MANTIS REDUX SPINAL SYSTEM STRYKER SPINE
K171496 05/22/2017 Tritanium C Anterior Cervical Cage STRYKER SPINE
K183249 11/21/2018 Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage STRYKER SPINE
K113666 12/13/2011 XIA 3 SPINAL SYSTEM STRYKER SPINE
K091946 06/30/2009 VLIFT-S VERTEBRAL BODY REPLACEMENT SYSTEM, MODELS 488812XX, 488814XX, 488816XX, 488818XX STRYKER SPINE
K102606 09/10/2010 AVS ANCHOR-C CERVICAL CAGE SYSTEM STRYKER SPINE
K100865 03/29/2010 AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX STRYKER SPINE
K101051 04/15/2010 AVS A-LAT PEEK SPACERS, MODELS 48750XXX, 48751XXX, 48752XXX, 48753XXX STRYKER SPINE
K132968 09/23/2013 UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM) STRYKER SPINE
K200666 03/13/2020 Stryker Xia 3 Power Adaptor Stryker Spine
K203205 10/30/2020 Navigated Spine Instruments Stryker Spine
K101183 04/28/2010 MODIFICATION TO: OASYS SYSTEM STRYKER SPINE
K093670 11/27/2009 MODIFICATION TO: OASYS SYSTEM STRYKER SPINE
K221490 05/23/2022 Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement Syste Stryker Spine
K183071 11/05/2018 VLIFT-s Vertebral Body Replacement System Stryker Spine
K222684 09/06/2022 XIA« 4.5 Spinal System, XIA« 4.5 Cortical Trajectory, XIA« 3 Spinal System, Serrato« Spinal System, XIA« Growth Rod Conversion Set, XIA« II Spinal System, XIA« Precision System, XIA« Anterior, Diapason« Spinal System, OpusÖ Spinal System, Radius« Spinal S Stryker Spine
K050189 01/27/2005 TECHTONIX SYSTEM STRYKER SPINE
K040261 02/04/2004 REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM STRYKER SPINE
K060361 02/13/2006 XIA SPINAL SYSTEM, XIA 4.5 SPINAL SYSTEM STRYKER SPINE
K050461 02/23/2005 XIA 4.5 SPINAL SYSTEM STRYKER SPINE
K060506 02/27/2006 STRYKER SPINE VLIFT VERTEBRAL BODY REPLACEMENT SYSTEM STRYKER SPINE
K070631 03/07/2007 DEVICE MODIFICATION TO RADIUS SPINAL SYSTEM STRYKER SPINE
K050624 03/11/2005 STRYKER SPINE AVS PL PEEK SPACER STRYKER SPINE
K060748 03/21/2006 MODIFICATION TO XIA 4.5 SPINAL SYSTEM STRYKER SPINE
K040731 03/22/2004 STRYKER SPINE VERTEBRAL SPACER STRYKER SPINE
K060979 04/10/2006 XIA TITANIUM AND 4.5 SPINAL SYSTEMS STRYKER SPINE
K051205 05/11/2005 STRYKER SPINE AVS ASL PEEK SPACER STRYKER SPINE
K071373 05/16/2007 STRYKER SPINE XIA III SPINAL SYSTEM STRYKER SPINE
K061813 06/27/2006 MANTIS SPINAL SYSTEM STRYKER SPINE
K061836 06/29/2006 AVS ASL PEEK SPACER SYSTEM STRYKER SPINE
K061854 06/30/2006 XIA TITANIUM SPINAL SYSTEM AND XIA STAINLESS STEEL SPINAL SYSTEM STRYKER SPINE
K051973 07/21/2005 MODIFICATION TO: XIA STAINLESS STEEL SYSTEM STRYKER SPINE
K062132 07/26/2006 AVS PL PEEK SPACER SYSTEM STRYKER SPINE
K062270 08/07/2006 RADIUS SPINAL SYSTEM STRYKER SPINE
K062310 08/08/2006 REFLEX HYBRID ACP SYSTEM STRYKER SPINE
K052181 08/10/2005 MODIFICATION TO XIA SPINAL SYSTEM STRYKER SPINE
K052317 08/25/2005 MODIFICATION TO: STRYKER SPINE OASYS SYSTEM STRYKER SPINE
K062698 09/11/2006 TRIO + SPINAL SYSTEM STRYKER SPINE
K072568 09/12/2007 MODIFICATION TO OASYS SYSTEM STRYKER SPINE
K042571 09/21/2004 STRYKER SPINE AVS TL PEEK SPACER STRYKER SPINE
K062853 09/25/2006 MODIFICATION TO STRYKER SPINE OASYS SYSTEM STRYKER SPINE
K052761 09/30/2005 MODIFICATION TO: XIA 4.5 SPINAL SYSTEM STRYKER SPINE
K052971 10/24/2005 STRYKER SPINE TRIO SPINAL FIXATION SYSTEM STRYKER SPINE
K053115 11/07/2005 XIA SPINAL SYSTEM STRYKER SPINE
K063430 11/13/2006 ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) SYSTEM STRYKER SPINE
K063428 11/13/2006 XIA STAINLESS STEEL SPINAL SYSTEM STRYKER SPINE
K043180 11/17/2004 STRYKER SPINE TRIO PS STRYKER SPINE
K073470 12/10/2007 AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX STRYKER SPINE
K043473 12/16/2004 MODIFICATION TO XIA SPINAL SYSTEM STRYKER SPINE
K113802 12/23/2011 ESCALATE LAMINOPLASTY SYSTEM STRYKER SPINE
K120486 02/17/2012 AVS AS PEEK SPACER STRYKER SPINE
K111719 06/20/2011 OASYS SPINAL SYSTEM STRYKER SPINE
K152532 09/03/2015 AERO -C Cervical Cage System STRYKER SPINE
K122845 09/17/2012 ES2 SPINAL SYSTEM MODEL 48280XXXX STRYKER SPINE
K133188 10/17/2013 MANTIS & MANTIS REDUX SPINAL SYSTEM, RADIUS SPINAL SYSTEM, TRIO & TRIO+ SPINAL FIXATION SYSTEMS, AND TRIO TRAUMA SPINAL STRYKER SPINE
K120869 03/22/2012 ANCHOR-L LUMBAR CAGE STRYKER SPINE
K110419 02/14/2011 AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS STRYKER SPINE
K161407 05/20/2016 Ascential IBD PEEKc Spacer Stryker Spine
K122637 08/29/2012 LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 STRYKER SPINE
K181014 04/17/2018 Tritanium PL Cage Stryker Spine


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