510(k) Report

Devices descending from K032064

1,280 later devices reach Theken Cpod/Lpod Vertebral Body Replacement System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+4K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+4K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+4K153665Prow Fusion-LNlt Spine, Ltd.20160—
+4K161485Nanovis Intervertebral Body Fusion System and Forticore (R)Nanovis, LLC20165—
+4K160605MectaLIF Anterior Stand-AloneMedacta International201610—
+4K153615NeoFuse HA Enhanced PLIF/TLIFHt Medical, LLC201650—
+4K153720ENZA Zero-Profile Anterior Interbody FusionCamber Spine Technologies20164—
+4K153413PASS LP Spinal SystemMedicrea International SA20160—
+4K152568C-VBRCardinal Spine, LLC201657—
+4K151939COALITION SpacersGlobus Medical, Inc.2016152—
+4K152793Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.201629—
+4K152972Amendia Stand-Alone Cervical SystemAmendia, Inc.201632
+4K151481Sahara Stabilization SystemK2m, Inc.20155—
+4K152515TOMCAT Cervical Spinal SystemChoicespine, LP2015108—
+4K153122Endoskeleton (r) TCS SystemTitan Spine, LLC20151061
+4K151934ROI-C Titanium-Coated Implant SystemLdr Spine USA20159—
+4K151596Endoskeleton TCS Interbody Fusion DeviceTitan Spine, LLC20151101
+4K150765LDR Spine ROI-C Cervical Cage SystemLdr Spine USA201559—
+4K150481Cascadia Interbody SystemK2m, Inc.20154593
+4K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small…Biomet Spine201517—
+4K151198A-CIFT SoloFuseSpinefrontier, Inc.20158—
+4K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+4K150362NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated2015441—
+4K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+4K150130Ascendant TM Cervical Spacer SystemExactech, Inc.20157—
+4K150913Incite Anchored Cervical Interbody DeviceIncite Innovation20150—
+4K142392Zavation Posterior LEIFZavation, LLC20150—
+4K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20159—
+4K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc.2015155—
+4K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+4K143214SCARLET® AC-T Secured Anterior Cervical CageSpineart20153—
+4K142030STGC-LordoticCardinal Spine, LLC201558—
+4K141599Divergence Anterior Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc.201516—
+4K142152Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone SystemOrthofix, Inc.2015280—
+4K142271Zavation Z-Link LumbarZavation, LLC20149—
+4K141537IN:C2 Spinal Fixation SystmeSpine Smith Holdings, LLC20140—
+4K141942Midline II TICentinel Spine, Inc.2014459—
+4K142016CAPRIK2m, Inc.201412—
+4K142050Nuvasive Coroent Small Contoured Interbody SystemNu Vasive, Incorporated2014449—
+4K141314Scarlet AC-T Secured Anterior Cervical Cage and Associated InstrumentationSpineart201438—
+4K141405Mobis II ST Spinal ImplantSignus Medizintechnik GmbH2014461—
+4K140280ForticoreNanovis, LLC20149—
+4K140921Coroent Small Interbody SystemNu Vasive, Incorporated2014444—
+4K133494Chesapeake Spinal SystemK2m, Inc.2014330—
+4K140529Everest Spinal SystemK2m, LLC201431—
+4K140303Alamo TAlliance Partners, LLC20140—
+4K133340Spineworks Anterior Lumbar DeviceSpineworks, LLC201413—
+4K133614Aleutian Ibf SystemK2m, Inc.2014527—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132991C-Box Peek Cervical IbfInnovasis, Inc.20149—
+4K132582Exactech Acapella One Cervical Spacer SystemExactech, Inc.2014471
+4K133286Midline (TM)Centinel Spine, Inc.2014460—
+4K132584Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2013119—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K130853Idys (TM) CClariance20132—
+4K130254Prow FusionNlt Spine, Ltd.20138—
+4K132361Everest Spinal SystemK2m, Inc.201334—
+4K130461Stalif XCentinel Spine, Inc.201313—
+4K130948C-Fuse Cervical Intervertebral Body Fusion SystemSouthern Spine, LLC201313—
+4K130820Expandable Lumbar Interbody SystemNu Vasive, Incorporated2013593—
+4K131671MectalifMedacta International201322—
+4K122801Providence Cervical CageProvidence Medical Technology, Inc.20131—
+4K124034Mectalif AnteriorMedacta International201311—
+4K130506Imse P-TlifInstitute of Musculoskeletal Science & Education20130—
+4K130306Incite Anchored Cervical Interbody DeviceIncite Innovation, LLC20131—
+4K122037Anatomic Peek Cervical Fusion System Cornerstone PSR Cervical Fusion System Peek Prevail…Medtronic Sofamor Danek, Inc.2013281—
+4K123993Solus Anterior Lumbar Interbody Fusion (Alif) SystemAlphatec Spine, Inc.20130—
+4K122872Intervertebral Body Fusion DeviceDio Medical Co., Ltd.201316—
+4K123134Easyspine SystemLdr Spine USA, Inc.20131—
+4K120603Varilift -CWenzel Spine2013193—
+4K121254Camber Spine Technologies TLS 5.0 Inerbody CageCamber Spine Technologies201340—
+4K121649Construx Mini Peek TI Spacer SystemOrthofix2012289—
+4K121151Pro-Link Cervical Spacer SystemLife Spine, Inc.2012116—
+4K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+4K122021Sterispine LC CageSafe Orthopaedics20122—
+4K120819Stalif CCentinel Spine, Inc.2012206—
+4K121211VU Apod Intervertebral Body Fusion DeviceTheken Spine, LLC2012129—
+4K120275Synthes Acis/Vertebral Spacer CRSynthes (Usa), LLC2012173—
+4K113796Solitaire-C Cervical Spacer SystemEbi, LLC20121421
+4K120368Capstone Control Spinal SystemMedtronic Sofamor Danek USA, Inc.2012761—
+4K112862Mecta-CMedacta International201114—
+4K112444Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danck USA, Inc.2011324—
+4K111264Cornerstone (R) PSR Cervical Fusion SystemMedtronic Sofamor Danek USA2011331—
+4K111439Chesapeake (Cervical Components)K2m, Inc.20113451
+4K100967Perimeter C Spinal SystemMedtronic Sofamor Danek USA, Inc.2011121—
+4K111675VU C*Pod Intervertebral Body Fusion DeviceTheken Spine, LLC201162—
+4K081564Creaspine Supstance Vertebral Body Replacement System Line ExtensionCreaspine20080—
+5K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+5K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+5K2530413d Cage CervicalFims Co., Ltd.20260—
+5K262094E3D™-C Interbody SystemEvolution Spine20260—
+5K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+5K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+5K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+5K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+5K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+5K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+5K261067BEE PLIF CageNGMedical GmbH20260—