510(k) Report

Devices descending from K071922

1,221 later devices reach Interplate Interbody Fusion Device, Models C, CGC, L and LGC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160291Optimus ALIF SystemAmendia, Inc.20160—
+4K151726AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK…Stryker Corporation20161391
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+4K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151773CONCORDE Bullet Lumbar Interbody SystemMedos International SARL2015201—
+4K152304Tritanium PL CageStryker20154481
+4K152259InFill Interbody Fusion DevicePinnacle Spine Group, LLC20152—
+4K152277PIVOX (tm) Oblique Lateral Spinal SystemMedtronic Sofamor Danek USA, Inc.2015190—
+4K150788Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…Meditech Spine, LLC2015202—
+4K151352CONCORDE Bullet Spinal SystemMedos International SARL20153—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K151727Everest Spinal SystemK2m, Inc.201511—
+4K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151128CAPSTONE Spinal System, CLYDESDALE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015255—
+4K151374NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable…Nu Vasive, Incorporated2015235—
+4K142645Avenue T TLIF CageLdr Spine USA, Inc.2015191—
+4K142559ELEVATE Spinal SystemMedtronic Sofamor Danek USA, Inc.2015130—
+4K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+4K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc.20154—
+4K143258PLIF STS, TLIF STS, OLIF STS (Spinal Truss System)4Web, Inc.2015211—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K143616AccuLIF TL and PL CageStryker Corporation20154694
+4K142498MAGNIFY and MAGNIFY-S SpacersGlobus Medical, Inc.2015175—
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+4K142360Everest Spinal SystemK2m, Inc.201522—
+4K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+4K142299CoRoent Small Interlock SystemNu Vasive, Incorporated201499—
+4K140716Opticage Expandable Interbody Fusion DeviceInterventional Spine, Inc.20140—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K133717Longbow Spacer SystemLife Spine20149—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K140411Altera SpacerGlobus Medical, Inc.201419122
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+4K133514Xcage Interbody Fusion SystemOuroboros Medical201415—
+4K132738Cogent Med-LifCogent Spine, LLC201413—
+4K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+4K134038Camber Spine Diagon Oblique CageCamber Spine201428—
+4K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+4K133645Perimeter C Spinal System, Capstone Spinal System, Capstone L Spinal System, Perimeter…Medtronic Sofamor Danek USA, Inc.20146—
+4K132559Monument SpacersGlobus Medical, Inc.2013166—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131350Calix Lumbar Spinal Implant SystemX-Spine Systems, Inc.2013214
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K123461Staxx (R) IB SystemSpine Wave, Inc.2013251
+4K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+4K123231Caliber SpacersGlobus Medical, Inc.2013657—
+4K123180Falcon SpacerSynthes (USA) Products, LLC2013147—
+4K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+4K113447Rise SpacerGlobus Medical, Inc.2012691—
+4K113527Opticage Interbody Fusion DeviceInterventional Spine, Inc.2012103—
+4K113465Acculif TL CageCoalign Innovations, Inc.2011718—
+4K112095Acculif TL-Peek Ibf CageCoalign Innovations, Inc.2011319—
+4K110226Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201190—
+4K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+4K093864Avs Align Peek Spacers Model 48328XXX, 48326XXXStryker Corp.2010637—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+5K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+5K242303MOD-COrthomod, LLC20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+5K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+5K250764SpineLinc Anterior Cervical Implant SystemLincotek Medical20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+5K252742Navigated InstrumentsTyber Medical, LLC20251—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—