510(k) Report

Devices descending from K073470

1,102 later devices reach Avs PL Peek Spacers, Models 48351XXX and 48353XXX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K153419NuVasive CoRoent Thoracolumbar SystemNu Vasive, Incorporated2016400—
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152651AccuLIF TL and PL CageStryker Corporation201530—
+4K143479Bluefin Interbody SystemTides Medical20152—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+4K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K142487Chesapeake Stabilization SystemK2m, Inc.201571
+4K141798Sypher Spacer SystemBiogennix, LLC20151—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K140864Veloxtm Interbody Fusion SystemU&I Corp.20149—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K132926Velofixtm Interbody Fusion SystemU&I Corp.201410—
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K131122S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, LLC2013269—
+4K124034Mectalif AnteriorMedacta International201311—
+4K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K121320C7 Anterior Cervical Intervertebral Fusion CageMedyssey Co, Ltd.20122—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K111983Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-XxxxxxZimmer Trabecular Metal Technology201131—
+4K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+4K100214Cornerstone PSR Cervical Interbody Fusion DeviceMedtronic Sofamor Danek2010389—
+5K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K261408SABER-XA SystemElevation Spine20260—
+5K261430TruLift Expandable SystemLife Spine, Inc.20260—
+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—
+5K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+5K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+5K260038E3D™-C Interbody SystemEvolution Spine20261—
+5K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.20260—
+5K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+5K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+5K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+5K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251060CORUS™ Navigation System-GXProvidence Medical Technology, Inc.20250—
+5K241525ExcelsiusXR™Globus Medical, Inc.20250—
+5K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+5K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+5K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+5K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+5K250373ProLift Expandable Spacer SystemLife Spine, Inc.20251—
+5K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+5K243668ProLift Pivot Expandable Spacer SystemLife Spine, Inc.20250—
+5K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+5K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+5K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+5K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+5K242589Scarlet® AL-TSpineart SA20240—
+5K241477aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20246—
+5K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+5K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+5K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+5K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+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—
+5K241846E3D™-C Interbody SystemEvolution Spine20246—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+5K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+5K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+5K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+5K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+5K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+5K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+5K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+5K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+5K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+5K240699SCARLET® AC-TiSpineart SA20240—
+5K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+5K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+5K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+5K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+5K232432E3D™-A Interbody SystemEvolution Spine20248—
+5K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+5K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+5K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+5K231899HAtetracell™-C Titanium Cervical IBF SystemInnovasis, Inc.20232—
+5K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+5K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+5K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+5K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+5K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+5K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+5K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+5K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D CervicalHt Medical D.B.A. Xenix Medical20232—