510(k) Report

Devices descending from K073109

907 later devices reach Stalif TT Intervertebral Body Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K151481Sahara Stabilization SystemK2m, Inc.20155—
+2K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+2K142487Chesapeake Stabilization SystemK2m, Inc.201571
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K141798Sypher Spacer SystemBiogennix, LLC20151—
+2K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+2K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+2K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+2K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+2K130445Vault Alif SystemSpinal USA20139—
+2K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+3K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+3K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+3K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+3K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+3K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230329F3D Interbody SystemCorelink, LLC20230—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+3K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K222561AlignAcuity Surgical Devices, LLC202214—
+3K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+3K220610SOLO-LAurora Spine, Inc.20220—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K214010Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA202249—
+3K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+3K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K210439NuVasive MOD-EX XLIF Interbody SystemNu Vasive, Incorporated20214—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K210271NuVasive Modulus ALIF SystemNu Vasive, Incorporated20215—
+3K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—