510(k) Report

Devices descending from K072253

1,250 later devices reach Synfix-LR Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+2K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+2K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+2K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+2K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+2K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+2K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+2K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+2K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+2K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+2K120024Mectalif TransforaminalMedacta International S.A.201223—
+2K112862Mecta-CMedacta International201114—
+2K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+2K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+2K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+2K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+2K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+2K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+2K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+2K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+2K103111Forza Spacer SystemOrthofix, Inc.20113431
+2K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+2K100698STCCCardinal Spine, LLC2011346—
+2K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+2K093762Synthes Zero-PSynthes Spine20103061
+2K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+2K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+2K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+2K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+2K101720Juliet OLSpineart2010259—
+2K092521ZUMA-CSeaspine, Inc.2010168—
+2K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+2K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+2K093675Interfuse Invertebral Body Fusion Device Model 9076Vertebral Technologies, Inc.20090—
+2K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+2K091988Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Vertebral Technologies, Inc.2009101—
+2K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+2K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+2K083661Avs TL Peek SpacersStryker Corp.2009757—
+2K083475Lucent MagnumSpinal Elements, Inc.2009834—
+2K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+2K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+2K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+2K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+2K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+3K261049Scala® TLSpineart SA20260—
+3K261408SABER-XA SystemElevation Spine20260—
+3K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+3K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+3K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+3K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+3K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+3K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemKyocera Medical Technologies, Inc.20230—
+3K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+3K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+3K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+3K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+3K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+3K221172FOCUS Interbody SystemOc Medical Devices20220—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K213791Unispace SA Cervical CageEdisoninno Co., Ltd.20222—
+3K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+3K213118Dakota ALIF SystemPrecision Spine, Inc.20220—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K213493Fortilink with TiPlus TechnologyParadigm Spine20220—
+3K203714NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System…Nu Vasive, Incorporated202166—
+3K212266FIX-C PEEK Anterior Cervical Interbody SystemJeil Medical Corporation20217—
+3K212524Anteralign Spinal System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek USA, Inc.202155—
+3K212653Catalyft LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.202127
+3K210573Velofix SA Cervical CageU&I Corporation20211—
+3K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+3K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+3K211769OneLIF Intervertebral Body Replacement SystemNovapproach Spine202112
+3K210521DEXA-C Cervical Interbody SystemAurora Spine, Inc.20210—
+3K201671A-Link ZAcuity Surgical Devices, LLC202125—
+3K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+3K203278INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Globus Medical, Inc.202135—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K203201NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL…Nu Vasive, Incorporated202194—
+3K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+3K200458Tailored-C Cervical Interbody Fusion SystemBespoke Technologies20203—
+3K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—