510(k) Report

Devices descending from K072970

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A.201613—
+2K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+2K152620Spine Wave Gen II Expandable Interbody SystemSpine Wave, Inc.20162—
+2K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+2K151581Leva Spacer SystemSpine Wave, Inc.20156—
+2K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K150285Leva (TM) Spacer SystemSpine Wave, Inc.20157—
+2K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+2K133717Longbow Spacer SystemLife Spine20149—
+2K141443Infront Lumbar Interbody Fusion SystemInfront Medical, LLC20142—
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K140759Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar…Medos International SARL2014204—
+2K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+2K140303Alamo TAlliance Partners, LLC20140—
+2K140007Abacus TM Spacer SystemSpine Wave, Inc.20144—
+2K133721Infill 41-Tlif Convex Oblique Device, Infill 43-Tlif Contour Oblique, Infill 44-Tlif…Pinnacle Spine Group, LLC20145—
+2K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+2K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+2K132559Monument SpacersGlobus Medical, Inc.2013166—
+2K133126K7 Lumbar SpacersK7, LLC20131—
+2K132719Staxx Ibl SystemSpine Wave, Inc.20137—
+2K124034Mectalif AnteriorMedacta International201311—
+2K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+2K122518Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…Bm Korea Co., Ltd.20133—
+2K123231Caliber SpacersGlobus Medical, Inc.2013657—
+2K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+2K122989Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC)2012171—
+2K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+2K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+2K122085Stingray Cervical CageOmni Surgical, LP Dba Spine36020120—
+2K122021Sterispine LC CageSafe Orthopaedics20122—
+2K121892Phantom Plus Ceramic Cage SystemAmedica Corp.20127—
+2K120576Zavation Ibf SystemZavation, LLC201232—
+2K120101Independence SpacerGlobus Medical, Inc.2012224—
+2K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+2K113447Rise SpacerGlobus Medical, Inc.2012691—
+2K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+2K113348Cougar SystemJohnson & Johnson2011591—
+2K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+2K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+2K103655Octane-C Interbody Fusion Device SystemExactech, Inc.2011481
+2K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+2K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K093093Small Plateau Spacer SystemLife Spine2010393—
+2K101051Avs a-Lat Peek Spacers, Models 48750XXX, 48751XXX, 48752XXX, 48753XXXStryker Spine2010641—
+2K100889Endoskeleton TCTitan Spine, LLC2010455—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+3K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20261—
+3K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+3K253260ORIO-3D Cage SystemSpineCraft20260—
+3K242303MOD-COrthomod, LLC20260—
+3K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+3K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+3K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+3K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+3K250769Dakota LP SystemPrecision Spine, Inc.20250—
+3K250560BEE HANGMedical GmbH20250—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+3K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+3K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+3K241525ExcelsiusXR™Globus Medical, Inc.20250—
+3K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+3K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K241738PYXIS 3D Titanium Cervical Cage systemGS Medical Co., Ltd.20241—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K234150Lucent® XPSpinal Elements20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—