510(k) Report

Devices descending from K080822

708 later devices reach VU Apod Intervertabral Body Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+1K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+1K123969XiphosDifusion Technologies201314—
+1K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+1K112493Pass LP Spinal SystemMedicrea International20111—
+1K112359Prow FusionNlt Spine, Ltd.2011601—
+1K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+1K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+1K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+2K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+2K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+2K181818Scarlet AL-TSpineart201864—
+2K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+2K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+2K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+2K153413PASS LP Spinal SystemMedicrea International SA20160—
+2K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+2K141942Midline II TICentinel Spine, Inc.2014459—
+2K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+2K133286Midline (TM)Centinel Spine, Inc.2014460—
+2K130254Prow FusionNlt Spine, Ltd.20138—
+2K130461Stalif XCentinel Spine, Inc.201313—
+2K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+2K124034Mectalif AnteriorMedacta International201311—
+2K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+2K111965Vusion (R) OSOrtho Development20110—
+3K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K242589Scarlet® AL-TSpineart SA20240—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+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—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+3K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+3K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+3K200048MectaLIF Anterior SimpleMedacta International S.A.20200—
+3K192906Mecta-C Stand AloneMedacta International S.A.20201—
+3K192993Scarlet AL-TSpineart20201—
+3K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+3K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+3K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+3K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+3K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+3K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+3K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+3K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+3K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+3K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+3K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+3K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+3K153123Genesys Spine Apache Interbody Fusion SystemGenesys Spine201612—
+3K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+3K151654Prow FusionNlt Spine, Ltd.20151—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+3K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+3K140770MLX - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2014269—
+3K140162AP Expandable Xlif SystemNuvasive, Inc.2014236—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+4K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+4K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—