510(k) Report

Devices descending from P960025

1,714 later devices reach Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K143228Ancora LLC Interbody Fusion DeviceFrontier Medical Devices, Inc.20150—
+4K143297Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody…Zimmer Spine, Inc.201519—
+4K141896Coroent SystemNu Vasive, Incorporated2014480—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K142095Renovis S134 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014254—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+4K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K140659Coroent Thoracolumbar ImplantsNu Vasive, Incorporated2014483—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K133200Stalif C (R)Centinel Spine, Inc.201410—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K132029Vault-C Intervertebral Body Fusion DeviceSpinal USA2013108—
+4K131429Reliance Cervical Ibf SystemReliance Medical Systems, LLC201324—
+4K131951Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc.201312—
+4K130478Sustain and Sustain Radiolucent SpacersGlobus Medical, Inc.2013256—
+4K123913Latis SpacerGlobus Medical, Inc.201388—
+4K130445Vault Alif SystemSpinal USA20139—
+4K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173—
+4K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+4K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+4K122097Patriot SpacersGlobus Medical, Inc.2012261—
+4K121116Plateau Spacer SystemLife Spine201213—
+4K120656Everest Spinal SystemK2m, Inc.201243—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K103382Intercontinental Plate-SpacerGlobus Medical, Inc.2011554—
+4K103729Infill Intervertebral Body Fusion DevicePinnacle Spine Group, LLC201122—
+4K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc.20111121
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K102293Caliber SpacerGlobus Medical, Inc.2011869—
+4K102313Patriot Transcontinental M SpacersGlobus Medical, Inc.2010361—
+4K092574Esl Spinal SystemEbi, L.P.2010181—
+4K092336C-Thru Spinal SystemEbi, L.P.2009492—
+4K091381Ibex Spinal SystemEbi, L.P.2009181—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+5K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+5K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+5K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+5K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+5K253604TiLink-L Navigation InstrumentsSurGenTec, LLC20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+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—
+5K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+5K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+5K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+5K250769Dakota LP SystemPrecision Spine, Inc.20250—
+5K250560BEE HANGMedical GmbH20250—
+5K252322SIros-X SystemGenesys Spine20250—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K250247panaSIa SI Fusion SystemWenzel Spine, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+5K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.20251—
+5K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+5K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—