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
K242280 08/02/2024 Vitoss« BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss« BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma« Bioactive Bone Graft Substitute,Vitoss« BA2X Bioactive Bone Graft Substitute, Vitoss« Bioactive Bone Graft Substitute Pack,Vitoss Stryker Spine
K113666 12/13/2011 XIA 3 SPINAL SYSTEM STRYKER SPINE
K242361 08/09/2024 OZARK Cervical Plate System; PYRENEES« Cervical Plate System; EVEREST« Spinal System; MESA« Spinal System; MESA« Small Stature Spinal System; CASPIAN« Spinal System; DENALI« Spinal System; DENALI« MI Spinal System; YUKON OCT Spinal System; Xia« 3 Spinal S 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
K063428 11/13/2006 XIA STAINLESS STEEL SPINAL SYSTEM STRYKER SPINE
K063430 11/13/2006 ZERO PROFILE ANTERIOR CERVICAL PLATE (ACP) 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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact