510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K161280Cervical Stand Alone SystemOrthofix, Inc.201614—
+4K153436LATERAL Spine Truss System4Web, Inc.20165—
+4K160051NuVasive® Interfixated Interbody SystemNu Vasive, Incorporated2016396—
+4K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+4K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+4K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+4K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+4K151310Amendia Interbody Fusion DevicesAmendia, Inc.2016169—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K151496Latitude-C Cervical Interbody Spacer SystemDegen Medical201513—
+4K150455RT2 Trabeculite Titanium Cervical Cage SystemRhausler, Inc.20150—
+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—
+4K150619CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer SystemOrthofix, Inc.2015107—
+4K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+4K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+4K151756Sterispine LC CageSafe Orthopaedics20150—
+4K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+4K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20158—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+4K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+4K150206InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20152—
+4K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+4K143126Renovis S141 Lumbar Interbody Cage SystemRenovis Surgical Technologies2015237—
+4K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer…Stryker Corporation2015636—
+4K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+4K142347Amedica Valeo II Interbody Fusion DeviceAmedica Corp.20145—
+4K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+4K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+4K140479Coroent XL-F SystemNu Vasive, Incorporated2014465—
+4K140142Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon)Choicespine, LP2014172—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K133893Sterispine LC CageSafe Orthopaedics20141—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K131077Life Spine Plateau Spacer SystemLife Spine201310—
+4K130445Vault Alif SystemSpinal USA20139—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+4K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+5K263049SABER-C SystemElevation Spine20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+5K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+5K260810Anteralign LS coverplateTyber Medical, LLC20260—
+5K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.20260—
+5K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+5K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+5K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC20250—
+5K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+5K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+5K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+5K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251617X-PAC® TLIF Expandable Posterior Cage System; X-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—
+5K250669Adaptix™ Interbody System with Titan nanoLOCK™ Surface TechnologyMedtronic Sofamor Danek USA, Inc.20250—
+5K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+5K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+5K250186GoLIF! Lumbar Interbody Fusion SystemGetset Surgical, SA20250—
+5K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+5K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+5K243188Cylox® STSignus Medizintechnik GmbH20250—
+5K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242826ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20240—
+5K241332aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar…Carlsmed, Inc.20245—
+5K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+5K241328aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF); aprevo®…Carlsmed, Inc.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+5K232345ATEC Posterior Navigated Disc Prep InstrumentsAlphatec Spine, Inc.20232—
+5K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+5K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—