510(k) Report

Devices descending from K101310

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+1K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+1K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+1K181818Scarlet AL-TSpineart201864—
+1K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+1K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+1K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+1K141942Midline II TICentinel Spine, Inc.2014459—
+1K133286Midline (TM)Centinel Spine, Inc.2014460—
+1K124034Mectalif AnteriorMedacta International201311—
+1K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+2K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+2K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+2K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+2K242589Scarlet® AL-TSpineart SA20240—
+2K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+2K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+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—
+2K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K221545MectaLIF Anterior ExtensionMedacta International S.A.202226
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+2K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+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—
+2K192993Scarlet AL-TSpineart20201—
+2K190877Juliet® Ti LL Lumbar Interbody DeviceSpineart201911
+2K183426MectaLIF Anterior Stand Alone ExtensionMedacta International S.A.20191—
+2K180963Roccia Alif, Roccia TlifSilony Medical GmbH20183—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K162236Ax Stand-Alone ALIF SystemInnovasis, Inc.201774—
+2K170455MectaLIF Anterior Stand AloneMedacta International S.A.20174—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+2K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiCentinel Spine, Inc.2015368—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+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—
+3K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+3K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+3K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+3K241321Juliet® Ti LL Lumbar Interbody DeviceSpineart SA20240—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+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—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+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—
+3K223326Axiom PSR SystemRestor3D202301
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+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—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+3K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+3K203076Mecta-C Stand Alone ExtensionMedacta International S.A.20200—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+3K190680Favo S-TlifSilony Medical GmbH20190—
+3K182139AXTi Titanium Stand-Alone ALIF SystemInnovasis, Inc.201972—
+3K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar SystemLife Spine, Inc.20182—
+3K180814CoreLink® M3™ Stand-Alone Anterior Lumbar SystemCorelink, LLC201818—
+3K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+3K180695FBC 921 (Alif)Fbc Device Aps20180—
+3K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…Centinel Spine, Inc.201812—
+3K180002Rampart One Lumbar Interbody Fusion DeviceSpineology, Inc.20182—
+3K173082Arco™-SA Lumbar Cage SystemNeurostructures, Inc.20185—
+3K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+3K163595IMPIX 3D Print CagesMedicrea International SA2017282
+3K170592NuVasive BASE Interfixated Titanium SystemNu Vasive, Incorporated2017186—
+3K162358T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution SystemSynthes USA Products, LLC2016127—
+3K161379ELSA SpacersGlobus Medical, Inc.2016155—
+3K161129Pillar SA PTCOrthofix, Inc.201619—
+3K160597INDEPENDENCE MIS SpacersGlobus Medical, Inc.2016111—
+3K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T…Ldr Spine USA20161891
+3K152475FORZA PTC Spacer SystemOrthofix, Inc.2016236—
+3K152943NuVasive Foundation-LL SystemNu Vasive, Incorporated2015187—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—