510(k) Report

Devices descending from K062083

1,252 later devices reach Synfix -LR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+3K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies201632—
+3K151665SUSTAIN Additional ImplantsGlobus Medical, Inc.2016119—
+3K152532AERO -C Cervical Cage SystemStryker Spine2015145—
+3K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+3K151214ALIF Interfixated SystemNu Vasive, Incorporated2015220—
+3K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+3K150135DIVERGENCE-L Anterior/Oblique Lumbar Fusion SystemMedtronic Sofamor Danek USA, Inc.2015228—
+3K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics201512—
+3K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+3K142940Endoskeleton TCS SystemTitan Spine, LLC20151112
+3K141135Juliet LLSpineart2014146—
+3K133827A-Link ZOsteo Vasive, LLC2014262
+3K142066Aero-LL Lumbar Cage SystemStryker Corporation20142—
+3K142277Juliet POSpineart2014119—
+3K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+3K140474Juliet OLSpineart2014120—
+3K132738Cogent Med-LifCogent Spine, LLC201413—
+3K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc.20145961
+3K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+3K133623C-PLUSPioneer Surgical Technology, Inc.2014598—
+3K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+3K133126K7 Lumbar SpacersK7, LLC20131—
+3K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+3K123045Brigade Standalone SystemNuvasive, Inc.2013696—
+3K123767Lanx Fusion System- SALanx, Inc.20133244
+3K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+3K120869Anchor-L Lumbar CageStryker Spine2012638—
+3K120203TM-400 DeviceZimmer Trabecular Metal Technology, Inc.201220—
+3K120345Honour Spacer SystemNexxt Spine, LLC2012212—
+3K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+3K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+3K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+3K120557Solitarie Peek Anterior Spinal System-to BE Called Colitaire 35Biomet Spine & Bone Healing Technologies20121—
+3K112561Nuvasive Coroent NO-Profile SystemNuvasive, Inc.201212—
+3K111792Mobis, Moval, Semial, Tetrismodel Peek and Titanium, Kimba Model Standard and MiniSignus Medizintechnik GmbH2012470—
+3K120024Mectalif TransforaminalMedacta International S.A.201223—
+3K112862Mecta-CMedacta International201114—
+3K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+3K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC201110—
+3K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+3K112014Zyston Straight Spacer SystemBiomet Spine2011174—
+3K112496Pioneer Crossfuse II Ibf/VBR SystemPioneer Surgical Technology, Inc.2011604—
+3K111166A-Wedge Anterior Interbody System (a-Wedge a.I.S.)Spineworks, LLC201123—
+3K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+3K103111Forza Spacer SystemOrthofix, Inc.20113431
+3K103814Pezo Interbody Cages SystemUlrich GmbH & Co. KG20114—
+3K100698STCCCardinal Spine, LLC2011346—
+3K102547Coroent Interlock SystemNuvasive, Inc.2011131—
+3K093762Synthes Zero-PSynthes Spine20103061
+3K101363VU Cpod Intervertebral Bodu Fusion DeviceMusculoskeletal Clinical Regulatory Advisers201078—
+3K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010175—
+3K100865Ava Navigator Peek Spacers, Model 48392XXX, 48393XXXStryker Spine2010637—
+3K100544Impix Lumbar Interbody DeviceMedicrea Technologies201001
+3K101720Juliet OLSpineart2010259—
+3K092521ZUMA-CSeaspine, Inc.2010168—
+3K093629Solitaire and Solitaire Peek Anterior Spinal SystemBiomet Spine20101431
+3K092540C-PS Peek Optima Cervical Interbody Spacer, L-PS Peek Optima Lumbar Interbody SpacerRsb Spine, LLC201045—
+3K093675Interfuse Invertebral Body Fusion Device Model 9076Vertebral Technologies, Inc.20090—
+3K091813Intrepid Spinal SystemMedtronic Sofamor Danek2009719—
+3K091988Modification to: Interfuse Intervertebral Body Fusion Device , Model 9076Vertebral Technologies, Inc.2009101—
+3K090816Stryker Spine Avs PL Peek SpacersStryker Corp.2009756—
+3K090166Avs Anterior Large Peek SpacersStryker Corp.2009683—
+3K083661Avs TL Peek SpacersStryker Corp.2009757—
+3K083475Lucent MagnumSpinal Elements, Inc.2009834—
+3K082406Expandable Peek-Optima ImplantEbi, L.P.2009527—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+3K082014Stryker Spine Avs PL Peek SpacersStryker Corp.2008837—
+3K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd.2008907—
+3K080758Avs PL Peek Spacers, Models 48351 and 48353Stryker Corp.20081,091—
+4K261049Scala® TLSpineart SA20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+4K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+4K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.20260—
+4K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+4K250599ExcelsiusGPS™ InstrumentsGlobus Medical, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+4K241396uCerv Flux™-C 3D Porous Titanium Cervical InterbodyUlrich Medical USA, Inc.20240—
+4K240699SCARLET® AC-TiSpineart SA20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+4K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+4K232123MectaLIF Anterior Lag ExtensionMedacta International S.A.20231—
+4K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+4K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+4K223688CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ InstrumentsMedos International Sàrl20230—
+4K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+4K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+4K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—