510(k) Report

Devices descending from K073348

1,021 later devices reach Lucent Magnum through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210044Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System…Spinal Elements, Inc.20211—
+1K133717Longbow Spacer SystemLife Spine20149—
+1K122967LucentSpinal Elements, Inc.2013615—
+1K110632Lucent or Lucent MagnumSpinal Elements, Inc.20126941
+1K081711Lucent Magnum+Spinal Elements, Inc.20080—
+1K081968Modification to LucentSpinal Elements, Inc.2008716—
+1K080822VU Apod Intervertabral Body Fusion DeviceTheken Spine, LLC20087081
+1K071983Aesculap Peek Intervertebral Body Fusion System: a Space, Cespace, Prospace, T-SpaceAesculap Implant Systems, Inc.20087881
+2K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+2K201721TruLift Expandable Spacer SystemLife Spine, Inc.20205—
+2K190721LongBow TiLife Spine, Inc.20190—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K182584Lucent® XPSpinal Elements, Inc.20183—
+2K181970MectaLIF Posterior ExtensionMedacta International S.A.20182—
+2K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+2K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+2K172185Tyber Medical PT Interbody Spacer SystemTyber Medical, LLC20177—
+2K170235Lucent®Spinal Elements, Inc.2017107—
+2K170919The TiBow Expandable Spacer SystemLife Spine, Inc.20171—
+2K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+2K153665Prow Fusion-LNlt Spine, Ltd.20160—
+2K152011Lucent Intervertebral Body Fusion DeviceSpinal Elements, Inc.2016106—
+2K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+2K143450Ackermann Intervertebral Body Fusion DeviceAckermann Instrumente GmbH20150—
+2K151056Aesculap T-Space PEEK and XP Spinal SystemAesculap Implant Systems, LLC20150—
+2K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+2K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+2K143740Battalion Universal Spacer SystemAlphatec Spine, Inc.2015247—
+2K150061Lucent; Lucent Ti-Bond SystemsSpinal Elements, Inc.2015135—
+2K142634Biomet Spine Fusion SystemBiomet Spine, LLC20155—
+2K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+2K140319Coroent TI-C SystemNuvasive, Inc.2014590—
+2K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+2K133947Irix-a Lumbar Integrated Fusion SystemX-Spine Systems, Inc.20142—
+2K132852Peek Cage for the Vertebral SpineNeoortho Produtos Ortopedicos S/A20140—
+2K132596Proposed OptimusCustom Spine, Inc.201451
+2K133205Capstone PTC Spinal System, Clydesdale PTC Spinal SystemMedtronic Sofamor Danek USA, Inc.2014124—
+2K131292Deroyal Spine Spacer SystemDeroyal Industries, Inc.20140—
+2K132421Aesculap Peek XP Spinal Implant SystemAesculap Implant Systems, Inc.201414—
+2K130573Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, DlifTyber Medical, LLC2013251—
+2K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+2K123100Intess Lumbar CageKalitec Direct, LLC20135—
+2K123969XiphosDifusion Technologies201314—
+2K112986Lateral Fusion DeviceIntegra Spine (Integra Lifesciences)2012126—
+2K111820Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageBm Korea Co., Ltd.201220—
+2K113478Plif CageEisertech, LLC2012269—
+2K112493Pass LP Spinal SystemMedicrea International20111—
+2K112359Prow FusionNlt Spine, Ltd.2011601—
+2K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+2K101310VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2010480—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+2K083311Aesculap Cespace Peek Intervertebral Body Fusion SystemAesculap Implant Systems, Inc.2009554—
+2K082712Theken Spine VU Epod and VU Lpod SystemTheken Spine, LLC2009118—
+3K261430TruLift Expandable SystemLife Spine, Inc.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+3K251016MectaLIF 3D MetalMedacta International S.A.20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+3K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+3K234150Lucent® XPSpinal Elements20240—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+3K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+3K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+3K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K220902Navagio Lumbar CageKalitec Medical, LLC20220—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212831MectaLIF ExtensionMedacta International S.A.20211—
+3K210590Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20210—
+3K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+3K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+3K210061ProLift Lateral HELO FixatedLife Spine, Inc.20213—
+3K203254Lucent 3D Spinal SystemSpinal Elements, Inc.20218—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+3K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+3K201692NuVasive Modulus XLIF Interbody SystemNu Vasive, Incorporated202067—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+3K200958MODULIF-A Anterior Lumbar Interbody Fusion SystemSpinal Stability, LLC20200—
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K200352Axis Spine Technologies ALIFAxis Spine Technologies, Ltd.20202—
+3K193457AUDERE Lumbar Spacer SystemMet One Technologies20201—
+3K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+3K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191788CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT…Medtronic Sofamor Danek USA, Inc.20200—
+3K192502Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System…Medtronic Sofamor Danek USA, Inc.20204—
+3K191477AEON-C Stand Alone SystemHuvexel Co., Ltd.201910—
+3K1803473d CageFims Co., Ltd.20190—