510(k) Report

Devices descending from K072970

1,094 later devices reach Patriot Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…Solco Biomedical Co., Ltd.20192—
+1K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.201912—
+1K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+1K181357PATRIOT® Lumbar Spacers, SUSTAIN® SpacersGlobus Medical, Inc.201897—
+1K161710Sagico Ibf System – Aria Lumbar, Sagico Ibf System – Arion CervicalSpinal Analytics & Geometrical Impant Co, LLC201741—
+1K152022SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION®…Globus Medical, Inc.2017149—
+1K152501Spinal Jaxx Interbody Fusion DeviceNeuropro Spinaljaxx, Inc.201601
+1K143578SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers…Globus Medical, Inc.2016210—
+1K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+1K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+1K141980Leva (TM) Spacer SystemSpine Wave, Inc.20159—
+1K140411Altera SpacerGlobus Medical, Inc.201419122
+1K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+1K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+1K131071Staxx Ibl SystemSpine Wave, Inc.20138—
+1K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+1K123913Latis SpacerGlobus Medical, Inc.201388—
+1K122097Patriot SpacersGlobus Medical, Inc.2012261—
+1K120401Alamo TAlliance Partners, LLC20121—
+1K112664Zavation Ibf SystemsZavation, LLC201137—
+1K110650Zyston Arc Interbody SpacerBiomet Spine (Aka Ebi, LLC)2011177—
+1K110454Cougar LS Lateral Cage SystemJohnson & Johnson2011602—
+1K102293Caliber SpacerGlobus Medical, Inc.2011869—
+1K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+1K100037Advanced Vertebral Solutions Express BFDAdvanced Vertebral Solutions, LLC20100—
+1K093242Patriot Transcontinental Llif SpacerGlobus Medical, Inc.2009921—
+1K082801Phantom Plus Cage SystemUs Spine2008643—
+1K082252Independence SpacerGlobus Medical, Inc.2008576—
+1K073502Vertebron VBR SystemVertebron, Inc.200812—
+2K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation20250—
+2K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+2K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+2K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+2K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+2K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+2K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+2K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+2K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+2K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+2K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+2K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+2K211740DualXAmplify Surgical, Inc.20211—
+2K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+2K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+2K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+2K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+2K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+2K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+2K193521Steerable Plateau TiLife Spine, Inc.20201—
+2K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+2K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+2K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+2K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+2K180909REVEL SpacersGlobus Medical, Inc.201837—
+2K180076Ti 3Z Interbody SystemZavation Medical Products, LLC20184—
+2K181030Rubicon Lumbar Interbody Fusion SystemRubicon Spine, LLC20180—
+2K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+2K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+2K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+2K180687Reliance Lumber IBF SystemReliance Medical Systems20188—
+2K171848FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO…Globus Medical, Inc.201755—
+2K173115COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and…Globus Medical, Inc.201783—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+2K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+2K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+2K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K170119Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.201711
+2K170157INDEPENDENCE® SpacersGlobus Medical, Inc.2017109—
+2K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek20176—
+2K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+2K171567IRIX-A Lumbar Integrated Fusion SystemX-Spine Systems, Inc.201701
+2K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+2K163581Navigated ELEVATE Inserter, Navigated Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.2017103—
+2K163246Leva Anterior Expandable Spacer SystemSpine Wave, Inc.20170—
+2K170243LOSPA IS TLIF & DLIF CagesCorentec Co., Ltd.20170—
+2K163364MOJAVE Expandable Interbody SystemK2m201725—
+2K1624024CIS® Marlin ACIF Cage SystemSolco Biomedical Co., Ltd.20171—
+2K162918Atlas Spine Expandable Interbody SystemAtlas Spine, Inc.201729—
+2K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc.20179—
+2K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+2K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL2016111—
+2K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.201612—
+2K160076XCage™ Interbody Fusion SystemOuroboros Medical, Inc.2016141
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K160646XYcor® Expandable Spinal Spacer SystemAlphatec Spine, Inc.201641—
+2K161405Valeo II Interbody Fusion Device SystemAmedica Corp.20164—
+2K160699VIRTU Lumbar Spacer SystemMet 1 Technologies, LLC20162—
+2K161223TransContinental® M Spacers and InterContinental® Plate-SpacersGlobus Medical, Inc.2016117—
+2K153517AnyPlus® Cervical PEEK Cage SystemGS Medical Co., Ltd.201612—
+2K160463Reliance Lumbar IBF SystemReliance Medical Systems, LLC201611—