510(k) Report

Devices descending from K003155

2,091 later devices reach Vertebral Body Replacement through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+7K141953Endoskeleton; TA Ibd and VBR, to and TT, Tas, TC, TLTitan Spine, LLC20142652
+7K141850Flospine Pedicle Screw SystemFlospine20140—
+7K142101Abacus (TM) Spacer SystemSpine Wave, Inc.20140—
+7K142381Xia 3 Spinal SystemStryker Corp.201483—
+7K142589Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS…Titan Spine, LLC2014106—
+7K142450DIVERGENCE Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.20146—
+7K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+7K133577Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc.2014256—
+7K133717Longbow Spacer SystemLife Spine20149—
+7K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+7K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+7K140280ForticoreNanovis, LLC20149—
+7K141988M.U.S.T Pedicle Screw SystemMedacta International201426—
+7K141044M.U.S.T. ExtensionMedacta International201416—
+7K133402K2M Modular HooksK2m, Inc.20140—
+7K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+7K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+7K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+7K140709Skyhawk Interbody Fusion SystemOrthofix, Inc.20147—
+7K132788Myspine Pedicle Screw Placement GuidesMedacta International201412—
+7K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+7K140303Alamo TAlliance Partners, LLC20140—
+7K132738Cogent Med-LifCogent Spine, LLC201413—
+7K132596Proposed OptimusCustom Spine, Inc.201451
+7K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+7K133614Aleutian Ibf SystemK2m, Inc.2014527—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K133221Arsenal Spinal Fixation SystemAlphatec Spine, Inc.20141502
+7K133350Revere Stabilization SystemGlobus Medical, Inc.201493—
+7K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+7K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+7K133967Interbody Cage SystemAurora Spine2014227—
+7K133369Tiger Spine SystemCorelink, LLC201429—
+7K132878M.U.S.T. ExtensionMedacta International201328—
+7K133188Mantis & Mantis Redux Spinal System, Radius Spinal System, Trio & Trio+ Spinal Fixation…Stryker Spine201384—
+7K133207Staxx (R) SystemSpine Wave, Inc.20131—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K131178Idys Lif CagesClariance201311—
+7K132303Implanet Spine SystemImplanet, S.A.201315—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K131888T2 XVBR Spinal System, T2 Altitude Expandable Corpectomy DeviceMedtronic Sofamor Danek, Inc.20130—
+7K131250Tiger Spine SystemCorelink, LLC201340—
+7K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+7K131784Range Spinal SystemK2m, Inc.201334—
+7K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+7K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+7K131343Reform Pedicle Screw SystemSpinal USA201331—
+7K130279Reform Pedicle Screw SystemSpinal USA201331—
+7K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+7K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+7K131030Range Spinal SystemK2m, Inc.201334—
+7K130330Range Spinal SystemK2m, Inc.201336—
+7K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+7K123487Gso GS1 Cannulated Screw SystemGold Standard Orthopaedics, LLC20130—
+7K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+7K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+7K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339—
+7K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+7K123134Easyspine SystemLdr Spine USA, Inc.20131—
+7K120603Varilift -CWenzel Spine2013193—
+7K123281Acculif TL-Peek CageCoalign Innovations, Inc.2013146—
+7K123752Acculif TL and PL CageCoalign Innovations, Inc.2013676—
+7K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+7K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+7K123246CD Horizon Spire Z Spinal SystemMedtronic Sofamor Danek20122—
+7K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+7K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+7K1217414-Web Cervical STS (Spinal Truss System)4-Web, Inc.201235—
+7K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+7K122021Sterispine LC CageSafe Orthopaedics20122—
+7K120819Stalif CCentinel Spine, Inc.2012206—
+7K121922Beacon Stabilization SystemGlobus Medical, Inc.20129—
+7K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+7K112459Synthes Zero-PSynthes Spine Co.Lp2011277—
+7K112068Synthes Zero-P Variable Angle (VA)Synthes Spine Co.Lp2011331
+7K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106—
+7K102323Cervical Standalone Intervertebral Body Fusion DeviceTheken Spine, LLC201062—
+7K101288Staxx XD SystemSpine Wave, Inc.201051
+7K094042Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek2010397—
+7K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+7K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+7K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097—
+7K082270Octane Vertebral Body Replacement (VBR) SystemVertiflex, Inc.200855—
+7K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089—
+8K263049SABER-C SystemElevation Spine20260—
+8K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+8K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+8K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+8K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+8K261430TruLift Expandable SystemLife Spine, Inc.20260—
+8K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+8K2530413d Cage CervicalFims Co., Ltd.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH20260—