510(k) Report

Devices descending from K020152

1,684 later devices reach Synthes Vertebral Spacer TI through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+7K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc.20166—
+7K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education20160—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+7K153786Prow Fusion-VNlt Spine, Ltd.20166—
+7K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+7K160522White Pearl Preferred Angle Anterior Cervical PlateOsseus Fusion Systems, LLC20160—
+7K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+7K160125Cascadia Interbody SystemK2m2016315—
+7K152200SurgTech Interbody SystemSurgtech, Inc.20160—
+7K160547Cascadia Interbody SystemK2m2016157—
+7K153782NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated2016390—
+7K153627NuVasive® TLX Interbody SystemNu Vasive, Incorporated2016252—
+7K152568C-VBRCardinal Spine, LLC201657—
+7K151939COALITION SpacersGlobus Medical, Inc.2016152—
+7K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+7K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+7K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+7K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+7K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+7K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+7K151472NuVasive CoRoent Lumbar SystemNu Vasive, Incorporated2015479—
+7K151322Amendia Interbody Fusion DevicesAmendia, Inc.20152261
+7K150481Cascadia Interbody SystemK2m, Inc.20154593
+7K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+7K151483Biomet Spine Fusion SystemBiomet Spine, LLC20154—
+7K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+7K150500Px PEEK IBF SystemInnovasis, Inc.201558—
+7K150994NuVasive CoRoent Thoracolumbar ImplantsNu Vasive, Incorporated2015402—
+7K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+7K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+7K142487Chesapeake Stabilization SystemK2m, Inc.201571
+7K142744Mecta-C TiPEEKMedacta International201512—
+7K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+7K142392Zavation Posterior LEIFZavation, LLC20150—
+7K143595NuVasive (R) CCX-L Interbody SystemNu Vasive, Incorporated2015253—
+7K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+7K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+7K142030STGC-LordoticCardinal Spine, LLC201558—
+7K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+7K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+7K142271Zavation Z-Link LumbarZavation, LLC20149—
+7K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+7K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+7K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+7K133717Longbow Spacer SystemLife Spine20149—
+7K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+7K140280ForticoreNanovis, LLC20149—
+7K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+7K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+7K140529Everest Spinal SystemK2m, LLC201431—
+7K140303Alamo TAlliance Partners, LLC20140—
+7K132738Cogent Med-LifCogent Spine, LLC201413—
+7K132596Proposed OptimusCustom Spine, Inc.201451
+7K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+7K133614Aleutian Ibf SystemK2m, Inc.2014527—
+7K140106S128 Anterior Lumbar Interbody Fusion (Alif) SystemRenovis Surgical Technologies, Inc.2014265—
+7K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+7K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+7K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+7K133557Juliet LL Lateral Lumbar CageSpineart2014147—
+7K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+7K132757Everest Spinal SystemK2m, Inc.201341—
+7K130853Idys (TM) CClariance20132—
+7K131178Idys Lif CagesClariance201311—
+7K132361Everest Spinal SystemK2m, Inc.201334—
+7K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+7K131671MectalifMedacta International201322—
+7K130699Aleutian Spinal SystemK2m, Inc.2013570—
+7K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+7K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+7K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+7K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+7K123767Lanx Fusion System- SALanx, Inc.20133244
+7K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+7K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+7K120603Varilift -CWenzel Spine2013193—
+7K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+7K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+7K123207Primalif TM Llif Unitary Peek Lateral Lumbar Interbody Fusion SystemOsteomed LP201216—
+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—
+7K122021Sterispine LC CageSafe Orthopaedics20122—
+7K120819Stalif CCentinel Spine, Inc.2012206—
+7K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+7K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC201225—
+7K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+7K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+7K120031Chesapeake Spinal SystemK2m, Inc.2012334—
+7K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+7K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+7K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+7K111122Aesculap Sibd XP Spinal SystemAesculap Implant Systems, Inc.2011460—
+7K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+7K103111Forza Spacer SystemOrthofix, Inc.20113431
+7K103169AleuttianK2m, Inc.2011572—
+7K102322Stingray Cervical Cage; Shark Implant (Plif); Bull Shark Implant (Plif); Tiger Implant…Omni Surgical, L.P.20116—