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
+3K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+3K123027Capstone (R) Spinal SystemMedtronic Sofamor Danek, Inc.2013709—
+3K131077Life Spine Plateau Spacer SystemLife Spine201310—
+3K130630Plateau Spacer System TitaniumLife Spine, Inc.201317—
+3K122588Vusion CS PlusOrtho Development Corp.2013206—
+3K124012Infill Oblique Tlif DevicePinnacle Spine Group, LLC20136—
+3K123913Latis SpacerGlobus Medical, Inc.201388—
+3K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+3K130445Vault Alif SystemSpinal USA20139—
+3K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+3K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+3K121693A-Wedge Anterior Interbody System (a-Wedge Ais)Sapphire Medical Group, Inc.201221—
+3K122097Patriot SpacersGlobus Medical, Inc.2012261—
+3K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+3K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+3K122896Cougar LS 15 Lateral Cage SystemMedos International SARL2012205—
+3K121760Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc.2012723—
+3K113285LDR Spine Usa Avenue L Interbody FusionLdr Spine USA, Inc.2012199—
+3K121982Sovereign Spinal SystemMedtronic Sofamor Danek2012155—
+3K121733Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201221—
+3K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120101Independence SpacerGlobus Medical, Inc.2012224—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K113540Reliance Lumbar Ibf SystemReliance Medical Systems, LLC201212—
+3K113348Cougar SystemJohnson & Johnson2011591—
+3K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc.201114—
+3K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K110045Interfuse DA Invertebral Body Fusion DeviceVertebral Technologies, Inc.20110—
+3K102293Caliber SpacerGlobus Medical, Inc.2011869—
+3K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+3K102277Interfuse T Invertebral Body Fusion DeviceVertebral Technologies, Inc.201098—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K090899Depuy Spine Lateral SystemDepuy Spine, Inc.2009932—
+3K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253213SAGI Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K253545Vulcan Spinal SystemK2m, Inc.20260—
+4K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+4K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+4K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+4K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+4K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241164IB3D™ PL Spinal SystemMedicrea International S.A.S. (Medtronic)202412
+4K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+4K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+4K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K232432E3D™-A Interbody SystemEvolution Spine20248—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+4K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+4K221894Lumbar Expandable lnterbody Spacers -Additional Indications/ImplantsGlobus Medical, Inc.20232—
+4K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+4K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+4K230329F3D Interbody SystemCorelink, LLC20230—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+4K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+4K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+4K223731NuVasive Modulus-C Interbody SystemNuvasive, Inc.202311—
+4K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+4K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+4K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+4K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+4K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+4K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+4K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+4K221858ZSFab Lumbar Interbody SystemZsfab, Inc.20224—
+4K221172FOCUS Interbody SystemOc Medical Devices20220—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+4K213417Ghost Spacer SystemLife Spine, Inc.20220—
+4K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+4K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—