510(k) Report

Devices descending from K101301

474 later devices reach Stalif Midline through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+1K181591Fixated Asfora BULLET CAGE® (FABC)Medical Designs, LLC20180—
+1K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+1K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+1K141187Impix Alif S/aMedicrea International SA201501
+1K141942Midline II TICentinel Spine, Inc.2014459—
+1K133286Midline (TM)Centinel Spine, Inc.2014460—
+1K130461Stalif XCentinel Spine, Inc.201313—
+1K124034Mectalif AnteriorMedacta International201311—
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+2K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+2K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+2K192906Mecta-C Stand AloneMedacta International S.A.20201—
+2K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+2K181818Scarlet AL-TSpineart201864—
+2K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+2K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+2K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K161379ELSA SpacersGlobus Medical, Inc.2016155—
+2K161129Pillar SA PTCOrthofix, Inc.201619—
+2K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+2K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+3K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+3K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+3K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+3K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+3K221447Southern Anterior Screw Fixated Cage (SASCA)Southern Medical (Pty), Ltd.20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203683CarboClear Lumbar Cage SystemCarbofix Orthpedics, Ltd.20211—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K201939GAIA Lumbar Interbody Fusion Device (LIFD) FamilyPrinterprezz20200—
+3K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+3K202190Oculus-SA Lumbar Cage SystemNeurostructures20200—
+3K201506Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…Meditech Spine, LLC20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K201087CORBEL SpacersGlobus Medical, Inc.202036—
+3K200338ProLift Lateral FixatedLife Spine, Inc.20205—
+3K193378CarboClear Lumbar Cage SystemCarboFix Orthopedics, Ltd.20202—
+3K192993Scarlet AL-TSpineart20201—
+3K191834Stand-Alone ALIF Titanium SystemLife Spine, Inc.20190—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K191391HEDRON Lumbar SpacersGlobus Medical, Inc.201984—
+3K183407Triton CageMedyssey USA, Inc.20190—
+3K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+3K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc.201942—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K182195Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20183—
+3K181397DualXInnovasive, Inc.201815—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—