510(k) Report

Devices descending from K080537

958 later devices reach L-Varlock through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+3K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K232611TruLift Micro Expandable Spacer System & TruLift Expandable Spacer SystemLife Spine, Inc.20232—
+3K232069Expandable Lumbar Fusion Cage (Type I,Type II)Shanghai Reach Medical Instrument Co, Ltd.20230—
+3K233191TotalTi ACDF by SAGICOSpinal Analytics & Geometrical Implant Co, LLC20230—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+3K221138Titus Titanium Cervical by SAGICOSagico VA USA, LLC20231—
+3K223143SAGICO Spinal SystemSagico VA USA, LLC20230—
+3K230894NuVasive Modulus ALIF SystemNu Vasive, Incorporated20234—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K223146EVOLUTION SPINE Interbody SystemEvolution Spine20239—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223153Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.20220—
+3K222009aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.202212—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+3K223065Adcura® Sagittae® Lateral Lumbar Interbody Fusion DevicesAdcura, Inc.20220—
+3K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221936Standalone ALIF Interbody Fusion SystemEminent Spine20222—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K213417Ghost Spacer SystemLife Spine, Inc.20220—
+3K222082aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal…Carlsmed, Inc.202211—
+3K221687Pegasus-X Expandable PLIF SystemGS Medical Co., Ltd.20220—
+3K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+3K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemMiRus, LLC20220—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+3K220655X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20222—
+3K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+3K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+3K211845Deploy Expandable Interbody SystemSouthern Spine, LLC20210—
+3K211740DualXAmplify Surgical, Inc.20211—
+3K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+3K211616ExcelsiusHubGlobus Medical, Inc.20219Class I
+3K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K203802X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20213—
+3K210425Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2021561
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+3K203361ProLift Wedge Expandable Spacer SystemLife Spine, Inc.20211—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K202034aprevo Intervertebral Body Fusion DeviceCarlsmed, Inc.202017—
+3K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K201145X-Pac Expandable Lumbar Cage SystemExpanding Innovations, Inc.20204—
+3K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek202079—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200047ExcelsiusGPS Cranial 1.0 ModuleGlobus Medical, Inc.202053
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K200816SpineEX Sagittae Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+3K193521Steerable Plateau TiLife Spine, Inc.20201—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K192115SABLE Expandable SpacerGlobus Medical, Inc.202037—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+3K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+3K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+3K183064TxTi IBF SystemInnovasis, Inc.2019481
+3K190684LxHA PEEK Lateral IBF SystemInnovasis, Inc.20190—
+3K191005ProLift® Expandable SystemLife Spine, Inc.201918—
+3K190165Capstone Control™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20196—
+3K182349Concorde LiftMedos International SARL20190—
+3K190193SpineEX Sagittae® Lateral Lumbar Interbody Fusion DevicesSpineex, Inc.20192—
+3K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemWenzel Spine, Inc.20195—
+3K180909REVEL SpacersGlobus Medical, Inc.201837—
+3K182584Lucent® XPSpinal Elements, Inc.20183—
+3K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+3K181860NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2018159—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+3K180373CancelleX Porous Titanium Lumbar Interbody DeviceXenco Medical, LLC20180—
+3K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+3K181261Curiteva Cervical Interbody Fusion SystemCuriteva, LLC20184—
+3K180675Atlas Spine Expandable Cervical Interbody SystemAtlas Spine, Inc.20182—
+3K173722PATRIOT COLONIAL Spacer, SUSTAIN SpacerGlobus Medical, Inc.201894—
+3K172480icotec Interbody Cage SystemIcotec AG20185—
+3K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+3K173537Concorde Lift™Medos International SARL20181—
+3K171312FortiCore®Nanovis, LLC20183—